Methods and systems for treating hydrocephalus

ABSTRACT

An endovascular shunt implantation system includes a guide member configured for being deployed in an inferior petrosal sinus, and a delivery catheter movably coupled to the guide member, wherein a distal end of the delivery catheter includes a tissue penetrating element. A guard is disposed over the tissue penetrating element, the guard having an open distal end portion including an inner surface feature configured to deflect the tissue penetrating element away from the guide member when the tissue penetrating element is translated distally relative to the guard. A shunt delivery shuttle is positioned within, and is movable relative to, the delivery catheter, the shunt delivery shuttle having a distal portion configured to collapse around an elongate shunt body to thereby transport the shunt body through the delivery catheter, wherein the distal portion self-expands to release the shunt body when the distal shuttle portion is advanced out of the delivery catheter.

The inventions disclosed herein relate to systems and methods foraccessing cerebral cisterns and draining cerebrospinal fluid (CSF),(e.g., to relieve elevated intracranial pressure), using an endovascularapproach. More particularly, the present disclosure pertains to systemsand methods for treatment of hydrocephalus, pseudotumor cerebri, and/orintracranial hypertension. The present application is related to U.S.patent application Ser. No. 14/929,066, filed on Oct. 30, 2015, which ishereby incorporated by reference into the present application in itsentirety.

FIELD OF THE INVENTION Background

Hydrocephalus is one of the most common and important neurosurgicalconditions affecting both, children and adults. Hydrocephalus, meaning“water on the brain,” refers to the abnormal CSF accumulation in thebrain. The excessive intracranial pressure resulting from hydrocephaluscan lead to a number of significant symptoms ranging from headache toneurological dysfunction, coma, and death.

Cerebrospinal fluid is a clear, physiologic fluid that bathes the entirenervous system, including the brain and spinal cord. Cells of thechoroid plexus present inside the brain ventricles produce CSF. Innormal patients, cells within arachnoid granulations reabsorb CSFproduced in the choroid plexus. Arachnoid granulations straddle thesurface of the intracranial venous drainage system of the brain andreabsorb CSF present in the subarachnoid space into the venous system.Approximately 450 mL to 500 mL of CSF is produced and reabsorbed eachday, enabling a steady state volume and pressure in the intracranialcompartment of approximately 8-16 cm H₂O. This reabsorption pathway hasbeen dubbed the “third circulation,” because of its importance to thehomeostasis of the central nervous system.

Hydrocephalus occurs most commonly from the impaired reabsorption ofCSF, and in rare cases, from its overproduction. The condition ofimpaired reabsorption is referred to as communicating hydrocephalus.Hydrocephalus can also occur as a result of partial or completeocclusion of one of the CSF pathways, such as the cerebral aqueduct ofSylvius, which leads to a condition called obstructive hydrocephalus.

A positive pressure gradient between the intracranial pressure of thesubarachnoid space and the blood pressure of the venous system maycontribute to the natural absorption of CSF through arachnoidgranulations. For example in non-hydrocephalic individuals, intracranialpressures (ICPs) can range from about 6 cm H20 to about 20 cm H20. ICPgreater than 20 cm H20 is considered pathological of hydrocephalus,although ICP in some forms of the disease can be lower than 20 cm H20.Venous blood pressure in the intracranial sinuses and jugular bulb andvein can range from about 4 cm H20 to about 11 cm H20 innon-hydrocephalic patients, and can be slightly elevated in diseasedpatients. While posture changes in patients, e.g., from supine toupright, affect ICP and venous pressures, the positive pressure gradientbetween ICP and venous pressure remains relatively constant. Momentaryincreases in venous pressure greater than ICP, however, can temporarilydisturb this gradient, for example, during episodes of coughing,straining, or valsalva.

Normal pressure hydrocephalus (NPH) is one form of communicatinghydrocephalus. NPH patients typically exhibit one or more symptoms ofgait disturbance, dementia, and urinary incontinence, which can lead tomisdiagnosis of the disease. Unlike other forms of communicatinghydrocephalus, NPH patients may exhibit little or no increase in ICP. Itis believed that the CSF-filled ventricles in the brain enlarge in NPHpatients to accommodate the increased volume of CSF in the subarachnoidspace. For example, while non-hydrocephalic patients typically have ICPsranging from about 6 cm H20 to about 20 cm H20, ICPs in NPH patients canrange from about 6 cm H20 to about 27 cm H20. It has been suggested thatNPH is typically associated with normal intracranial pressures duringthe day and intermittently increased intracranial pressure at night.

Other conditions characterized by elevated intracranial pressure includepseudotumor cerebri (e.g., benign intracranial hypertension). Theelevated ICP of pseudotumor cerebri causes symptoms similar to, but thatare not, a brain tumor. Such symptoms can include headache, tinnitus,dizziness, blurred vision or vision loss, and nausea. While most commonin obese women 20 to 40 years old, pseudotumor cerebri can affectpatients in all age groups.

Prior art techniques for treating communicating hydrocephalus (and insome cases, pseudotumor cerebri and intracranial hypertension) rely onventriculoperitoneal shunts (“VPS” or “VP shunt” placement), a medicaldevice design introduced more than 60 years ago. VPS placement involvesan invasive surgical procedure performed under general anesthesia,typically resulting in hospitalization ranging from two to four days.The surgical procedure typically involves placement of a siliconecatheter in the frontal horn of the lateral ventricle of the brainthrough a burr hole in the skull. The distal portion of the catheterleading from the lateral ventricle is then connected to a pressure orflow-regulated valve, which is placed under the scalp. A separateincision is then made through the abdomen, into the peritoneal cavity,into which the proximal portion of a tubing catheter is placed. Thecatheter/valve assembly is then connected to the tubing catheter, whichis tunneled subcutaneously from the neck to the abdomen.

VPS placement is a very common neurosurgical procedure, with estimatesof 55,000-60,000 VPS placements occurring in the U.S. each year. Whilethe placement of a VP shunt is typically well-tolerated by patients andtechnically straightforward for surgeons, VP shunts are subject to ahigh rate of failure in treated patients. Complications from VP shuntplacement are common with a one-year failure rate of approximately 40%and a two-year shunt failure rate reported as high as 50%. Commoncomplications include catheter obstruction, infection, over-drainage ofCSF, and intra-ventricular hemorrhage. Among these complications,infection is one of the most serious, since infection rates in adultsare reported between 1.6% and 16.7%. These VPS failures require “shuntrevision” surgeries to repair/replace a portion or the entirety of theVP shunt system, with each of these revision surgeries carrying the samerisk of general anesthesia, post-operative infection, and associatedcost of hospitalization as the initial VPS placement; provided, howeverthat shunt infections can cost significantly more to treat (e.g., threeto five times more) compared to initial VP shunt placement. Often theseinfections require additional hospital stays where the proximal portionof the VPS is externalized and long-term antibiotic therapy isinstituted. The rate of failure is a constant consideration byclinicians as they assess patients who may be candidates for VPSplacement. Age, existing co-morbidities and other patient-specificfactors are weighed against the likelihood of VP shunt failure that isvirtually assured during the first 4-5 years following initial VP shuntplacement.

Despite significant advances in biomedical technology, instrumentation,and medical devices, there has been little change in the design of basicVPS hardware since its introduction in 1952.

SUMMARY

In accordance with one aspect of the disclosed inventions, anendovascular shunt implantation system is provided, the system includinga guide member having a distal portion configured for being deployed inan inferior petrosal sinus (IPS) of a patient; a delivery cathetermovably coupled to the guide member, wherein a distal end of thedelivery catheter includes a tissue penetrating element, such that thedelivery catheter and tissue penetrating element are translatablerelative to the distal portion of the guide member within the IPS. Thesystem further includes a guard is at least partially disposed over, andmovable relative to, the tissue penetrating element. Optionally, an opendistal end portion of the guard includes an inner surface featureconfigured to deflect the tissue penetrating element away from the guidemember when the tissue penetrating element is translated distallyrelative to the guard. Optionally, the system further includes a shuntdelivery shuttle at least partially positioned within a lumen of, andmovable relative to, the delivery catheter, the shunt delivery shuttlecomprising an elongate proximal pusher coupled to a distal shuttleportion made of mesh or a cut tube and configured to collapse around anelongate shunt body to thereby transport the shunt body through thedelivery catheter lumen. The distal shuttle portion preferablyself-expands to release the shunt body when the distal shuttle portionis advanced out of the delivery catheter lumen through the opening ofthe tissue penetrating element.

In exemplary embodiments, the system further includes an expandableanchor configured for being deployed in a dural venous sinus of thepatient at a location distal to a target penetration site located on acurved portion of the IPS wall, wherein the elongate guide member iscoupled to, and extends proximally from, the anchor. Optionally, thesystem further includes a guide member pusher tool configured fortranslating the respective guide member and anchor relative to therespective IPS and dural venous sinus (which may be the IPS). In variousembodiments, the pusher tool comprises a handle having a lumen extendingthere through, and a tubular body portion coupled to the handle, thetubular body portion having a lumen that is contiguous with or otherwiseextends through the handle lumen, the respective handle and tubular bodylumens being configured to receive the guide member, wherein the handleis configured to allow selective engagement and release of a portion ofthe guide member extending proximally through the handle lumen forthereby pushing the guide member, and thus the anchor, distally.

In various embodiments, the guard includes a tubular guard body having afirst guard body lumen or recess configured to receive the penetratingelement, and a plurality of pull wires, each pull wire having a distalportion fixed within or otherwise attached to the guard body, whereinthe pull wires are configured to translate the guard body proximally ordistally relative to the delivery catheter so as to at least partiallyexpose or cover, respectively, the penetrating element. The open distalend portion of the guard member preferably has a beveled or taperedportion, and wherein the inner surface feature is located on the beveledor tapered portion. In various embodiments, the inner surface feature ofthe guard member is formed by at least a partial bead of materialapplied to, or molded as part of, an inner surface of the guard member.

In various embodiments, the system further comprises an endovascularshunt device, which may also be provided separately from the system. Theshunt device includes an elongate shunt body made out of a flexibleunreinforced polyurethane-silicone blend or other polymer, and a distalshunt anchor coupled to a distal end of the shunt body, wherein thedistal shunt anchor self-expands when advanced out of the deliverycatheter lumen. The shunt device further includes one or morecerebrospinal fluid (CSF) intake openings in a distal portion of theshunt that are in fluid communication with a shunt lumen extendingthrough the shunt body, the shunt body comprising one or morelongitudinal slits configured to allow egress there through of CSF inthe shunt lumen if a fluid pressure within the shunt lumen exceeds abody fluid pressure external of the one or more slits, and wherein aproximal end of the shunt body is fluidly sealed. In an exemplaryembodiment, the shunt device includes a tubular connector having aproximal portion secured to a distal end of the shunt body, a distalportion secured to the distal shunt anchor, and an open distal endlocated within the distal shunt anchor, wherein the one or more CSFintake openings comprise a single CSF intake opening located in thedistal end of the tubular connector. The tubular connector may beradiopaque or otherwise have one or more radiopaque elements coupledthereto. In some embodiments, the one or more longitudinal slits in thetubular body portion are configured and dimensioned to achieve a targetflow rate of 5 ml of CSF per hour to 15 ml of CSF per hour through theCSF drainage lumen under normal differential pressure conditions betweenthe CP angle cistern and venous system of the patient. In someembodiments, the one or more longitudinal slits in the tubular bodyportion are configured and dimensioned to allow CSF egress out of theCSF drainage lumen at a pressure differential between the CP anglecistern and the venous system of the patient in a range of 3 mm Hg to 5mm Hg.

In accordance with another aspect of the disclosed inventions, a pushertool is provided for deploying an elongate member (e.g., a solid guidewire or a hollow catheter) through a body lumen. In an exemplaryembodiment, the pusher tool includes a handle having a lumen extendingthere through; and a tubular body portion coupled to the handle, thetubular body portion comprising a lumen that is contiguous with orotherwise extends through the handle lumen, the respective handle andtubular body lumens being configured to receive an elongate member therethrough, wherein the handle is configured to allow selective engagementand release of a portion of the elongate member extending proximallythrough the handle lumen for thereby pushing the elongate memberdistally. In a preferred embodiment, the handle comprises a proximalfacing surface configured to mate with a human thumb or finger in orderto selectively engage or release the elongate member using said thumb orfinger.

In accordance with yet another aspect of the disclosed inventions, amethod for deploying an elongate member (e.g., a guide wire or catheter)into a body lumen of a patient using the above-described pusher toolincludes the steps of (a) inserting an elongate member through therespective handle and tubular body portion lumens of the pusher tool;(b) grasping the pusher tool (e.g., using a single hand); (c) pinchingto thereby secure a portion of the elongate member against a proximalfacing surface of the handle (e.g., using a finger or thumb of the samehand that is grasping the tool); (d) advancing the pusher tool whilemaintaining the pinched engagement of the elongate member against thehandle surface so as to advance the elongate member distally into, orfurther into, the body lumen; (e) releasing the engaged portion of theelongate member from the handle surface; and (f) withdrawing the pushertool proximally relative to the elongate member, wherein the method mayfurther include repeatedly performing steps (c) through (f) until adistal end portion of the elongate member is positioned at a targetedlocation in the patient's body.

In instances in which the body lumen is a blood vessel, the elongatemember is normally advanced into the blood vessel through an introducersheath having a proximal opening outside of the patient and a distalopening within the blood vessel, in which case advancing the pusher toolmay include advancing a distal portion of the tubular body into theproximal opening of the introducer sheath. The proximal opening of theintroducer sheath is normally accessed via a proximal introducer hub, inwhich case the method may further include grasping to thereby stabilizethe introducer hub while advancing the distal portion of the tubularbody through the hub.

Other and further aspects and features of embodiments will becomeapparent from the ensuing detailed description in view of theaccompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic diagram of a head of a human patient;

FIG. 2A-D are cross-sectional views of a portion of the head of a humanpatient;

FIG. 3A-J are side, perspective and cross-sectional views of an anchorand elongate guide member, according embodiments of the disclosedinventions;

FIG. 4A-C are perspective and cross-sectional views of an anchor andelongate guide member, according another embodiment of the disclosedinventions;

FIGS. 5A-W are perspective and cross-sectional views of an anchor,according other embodiments of the disclosed inventions;

FIG. 6 is a side view of a delivery assembly according to embodiments ofthe disclosed inventions;

FIGS. 7A-F are cross-sectional views of exemplary methods of deliveringthe anchor, the elongate guide member and the shunt at a target site,according embodiments of the disclosed inventions.

FIGS. 8A-B are perspective and cross-sectional views of a deliverycatheter, constructed according to embodiments of the disclosedinventions;

FIG. 9 is cross-sectional view of another delivery catheter, constructedaccording to another embodiment of the disclosed inventions;

FIGS. 10A-J are perspective, side and cross-sectional views of adelivery catheter, according to another embodiment of the disclosedinventions;

FIG. 11 is a perspective view of an elongated member of the deliverycatheter, constructed according to embodiments of the disclosedinventions

FIGS. 12A-E are side, perspective and cross-sectional views of anelongated member of the delivery catheter, constructed according toother embodiments of the disclosed inventions;

FIG. 13 is a perspective view of an elongated pusher constructedaccording to embodiments of the disclosed inventions;

FIGS. 14A-F are perspective views of exemplary methods for the elongatedpusher of FIG. 13 use, according to embodiments of the disclosedinventions;

FIGS. 15A-J are side, perspective and cross-sectional views of a shunt,constructed according to another embodiments of the disclosedinventions;

FIG. 16 is a cross-sectional views of an alternative delivery catheter,constructed according to embodiments of the disclosed inventions;

FIGS. 17A-C are side, perspective and cross-sectional views of anelongated guide member, constructed according to an alternativeembodiment of the disclosed inventions;

FIGS. 18A-E are side, perspective and cross-sectional views of theinterface between the elongated guide member and the anchor, accordingto embodiments of the disclosed inventions;

FIGS. 19A-I are perspective and cross-sectional views of a deliveryassembly having a penetrating element guard, according to embodiments ofthe disclosed inventions;

FIG. 20 is a sidecross-sectional view of an penetrating element guard,constructed according to an alternative embodiment of the disclosedinventions;

FIGS. 21A-M are side, perspective and cross-sectional views of adelivery catheter, constructed according to alternative embodiments ofthe disclosed inventions;

FIGS. 22A-F are side, perspective and cross-sectional views of a shuntconstructed according to embodiments of the disclosed inventions;

FIGS. 23A-B are side, perspective and cross-sectional views of shunt,pusher member and catheter interface according to embodiments of thedisclosed inventions;

FIGS. 24A-F are side, perspective and cross-sectional views of shunt andpusher member interface according to embodiments of the disclosedinventions;

FIGS. 25A-O are side, perspective and cross-sectional views of valvesconstructed according to embodiments of the disclosed inventions;

FIGS. 26A-D are side, perspective and cross-sectional views of anothervalve constructed according to embodiments of the disclosed inventions;

FIGS. 27A-D are side, perspective and cross-sectional views of yetanother valve constructed according to embodiments of the disclosedinventions;

FIGS. 28A-Q are side, perspective and cross-sectional views of valvesconstructed according to further embodiments of the disclosedinventions;

FIG. 29 is a perspective of another valve constructed according toembodiments of the disclosed inventions;

FIGS. 30A-E are side, perspective and cross-sectional views of anothershunt delivery catheter, constructed according to alternativeembodiments of the disclosed inventions; FIGS. 30F-G are side andcross-sectional views of a reinforcing member of the shunt deliverycatheter of FIGS. 30A-E, constructed according to embodiments of thedisclosed inventions.

FIGS. 31A-G are perspective and side views of a marker constructedaccording to embodiments of the disclosed inventions;

FIG. 32 is a perspective view of an implanted shunt according to theembodiments of the disclosed invention;

FIGS. 33A-40C are perspective and cross-sectional views of variousembodiments of distal anchoring mechanisms of the shunt, constructedaccording to the embodiments of the disclosed invention;

FIGS. 41A-48B are perspective and cross-sectional views of variousembodiments of shunt bodies, constructed according to the embodiments ofthe disclosed invention;

FIGS. 49A-54B are perspective and cross-sectional views of variousembodiments of implanted shunts according to the embodiments of thedisclosed invention;

FIGS. 55A-O are perspective and cross-sectional views of exemplarymethods for anchor delivery and shunt implantation procedures, accordingembodiments of the disclosed inventions;

FIGS. 56A-58F are perspective, side and cross-sectional views of shuntsconstructed according to alternative embodiments of the disclosedinventions;

FIGS. 59-62E are perspective and cross-sectional views of shunt deliveryshuttles constructed according to embodiments of the disclosedinventions;

FIGS. 63A-E are perspective views of a shunt and a shunt deliveryshuttle interface according to embodiments of the disclosed inventions;

FIGS. 64A-D are perspective and cross-sectional views of a penetratingelement guard constructed according to alternative embodiments of thedisclosed inventions;

FIGS. 65A-C are side and perspective views of radiopaque markersconstructed according to embodiments of the disclosed inventions;

FIG. 66 is perspective view of a handle assembly constructed accordingto embodiments of the disclosed inventions; and

FIGS. 67A-I are side views of a shunt pusher constructed according toembodiments of the disclosed inventions.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

For the following defined terms, these definitions shall be applied,unless a different definition is given in the claims or elsewhere inthis specification.

All numeric values are herein assumed to be modified by the term“about,” whether or not explicitly indicated. The term “about” generallyrefers to a range of numbers that one of skilled in the art wouldconsider equivalent to the recited value (i.e., having the same functionor result). In many instances, the terms “about” may include numbersthat are rounded to the nearest significant figure.

The recitation of numerical ranges by endpoints includes all numberswithin that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4,and 5).

As used in this specification and the appended claims, the singularforms “a”, “an”, and “the” include plural referents unless the contentclearly dictates otherwise. As used in this specification and theappended claims, the term “or” is generally employed in its senseincluding “and/or” unless the content clearly dictates otherwise.

Various embodiments are described hereinafter with reference to thefigures. The figures are not necessarily drawn to scale, the relativescale of select elements may have been exaggerated for clarity, andelements of similar structures or functions are represented by likereference numerals throughout the figures. It should also be understoodthat the figures are only intended to facilitate the description of theembodiments, and are not intended as an exhaustive description of theinvention or as a limitation on the scope of the invention, which isdefined only by the appended claims and their equivalents. In addition,an illustrated embodiment needs not have all the aspects or advantagesshown. An aspect or an advantage described in conjunction with aparticular embodiment is not necessarily limited to that embodiment andcan be practiced in any other embodiments even if not so illustrated.

FIG. 1 is a schematic diagram showing the head 100 of a human patient.Within each side of the patient's head, an inferior petrosal sinus (IPS)102 connects a cavernous sinus (CS) 104 to a jugular vein 106 and/or ajugular bulb 108. For clarity, the acronym “IPS” is used herein to refergenerally to the inferior petrosal sinus and more particularly to theinterior space (or lumen) of the inferior petrosal sinus. The IPS 102facilitates drainage of venous blood into the jugular veins 106. In somepatients, the junction of the IPS 102 and the jugular vein 106 occurswithin the jugular bulb 108. However, in other patients, this junctioncan occur at other locations in the jugular vein 106. Moreover, whilethe IPS 102 in FIG. 1 is a single sinus passageway, in some patients theIPS can be a plexus of separate channels that connect the CS to jugularvein 106 (not shown) and/or jugular bulb 108.

Embodiments of the disclosed inventions are described with respect to atarget penetration site in the IPS 102 to access the CSF-filled CP anglecistern 138, which provide a conduit for CSF to flow, via an implantedshunt device, from the subarachnoid space 116 into the jugular bulb 108,jugular vein 106 (FIGS. 1, 2A-B) and/or the superior vena cava-rightatrium junction (not shown). The delivery assemblies and shuntsdescribed herein can access the target penetration site in the IPS 102through a venous access location in the patient. The delivery assembliesand shunts described herein can penetrate the dura mater IPS wall 114and the arachnoid layer 115 to access the CP angle cistern 138 fromwithin a superior petrosal sinus (SPS) 122 (FIG. 1) for delivery andimplantation of the shunt at the target site. The dura mater IPS wall114 is also referred to herein as the dura IPS wall 114, or simply asthe IPS wall 114. The SPS is a small diameter venous sinus that connectsfrom the sigmoid sinus (distally located to jugular bulb 108) to thecavernous sinus 104 (1). Further, the delivery assemblies and shuntsdescribed herein can be advanced through the IPS 102 and into thecavernous sinus 104, so that an anastomosis (not shown) can be createdin the upper portion or roof of the cavernous sinus 104 to access theCSP-filled suprasellar cistern 148, shown in 1, for implantation of theshunt at such target site. Whether penetration to access a target site,deployment and implantation of a shunt occurs from the lumen of the SPSor cavernous sinus to access CSF in the subarachnoid space, theembodiments of the inventions described herein provide a conduit for CSFto flow from the subarachnoid space into the jugular bulb 108, jugularvein 106, and/or the superior vena cava-right atrium junction (notshown).

FIG. 2A shows a cross-sectional view of a portion of head 100, includingIPS 102, jugular vein 106, and jugular bulb 108. In addition, basilarartery 110, brain stem 112, pia 112 a, and IPS wall 114 are also shownin FIG. 2A. The IPS is a relatively small diameter intracranial venoussinus that facilitates drainage of cerebral venous blood into thejugular vein; the IPS is formed by a cylindrical layer of dura mater,typically about 0.9 mm to 1.1 mm thick for the portion of IPS wall 114shown in FIG. 2A, which creates a hollow lumen through which bloodflows. In the cross-section view of FIG. 2A, the hollow lumen of the IPSresides between upper IPS wall 114 and a lower IPS wall 117, alsocomprised of dura mater; the IPS itself lies in a bony groove or channelin the clivus bone (not shown) beneath IPS wall 117 in FIG. 2A.

A cross-section of the IPS 102 orthogonal to the plane depicted in FIG.2A would show that the cylindrical layer of dura mater forming IPS 102is surrounded by bone for about 270° of its circumference with theremaining portion of the IPS circumference (i.e., IPS wall 114 in FIGS.2A-B) covered by arachnoid matter 115 and facing CP angle cistern 138.Arachnoid mater 115 (also referred to herein as the arachnoid layer) isa delicate and avascular layer, typically about 0.05 mm to 0.15 mmthick, that lies in direct contact with the dura mater comprising theexterior of IPS wall 114; arachnoid layer 115 is separated from the piamater surrounding brain stem 112 by the CSF-filled subarachnoid space116 (e.g., CP angle cistern 138). The lower portion of the IPS 102,opposite to the IPS wall 114 is the IPS wall 117 formed by dura materthat sits in a channel in the clivus bone (not shown).

It should be appreciated that for the embodiments of the disclosedinventions, the methods and devices are configured to create ananastomosis via an endovascular approach by piercing or penetrating fromwithin the hollow IPS 102 to pass through the dura of IPS wall 114, andcontinue penetrating through the arachnoid layer 115 until reaching theCSF-filled subarachnoid space 116 (e.g., CP angle cistern 138). For easeof illustration, it should be appreciated that the arachnoid matter 115covering the IPS wall 114 is present, although, not shown in certainfigures.

The diameter d₁ of IPS 102 is approximately 3 mm but can range fromapproximately 0.5 mm to about 6 mm. As shown in FIG. 2A, at the junction118 between the IPS 102 and the jugular bulb 108 and/or jugular vein106, the diameter d₂ of the IPS 102 can narrow. For example, d₂ isapproximately 2 mm, but can be as small as about 0.5 mm. The length ofthe IPS 102 from the junction 118 with the jugular vein 106 to thecavernous sinus 104 (shown in FIG. 1) is approximately in a rangebetween 3.5 cm to 4 cm.

In many patients, the IPS 102 is coupled to the jugular vein 106 at alocation disposed below of the jugular bulb 108, depicted as junction118, shown in FIG. 2B. The IPS 102 extends distally from the junction118 in the medial wall of the jugular vein 106, past the 9th cranialnerve 111A and jugular tubercle (not shown) while curvingrostral-medially through a first curved portion 102A shown in FIG. 2C,and then further curving medial-superiorly through a second curvedportion 102B shown in FIG. 2C before connecting at the connection point111B with the cavernous sinus (CS) 104. The IPS 102 extends distallyfrom the junction 118 through a curvature of approximately 45° to 100°in the first and second curved portions 102A and 102B until the IPS 102connects with the CS 104. The CSF-filled CP angle cistern 138 liesimmediately above the curved portion of the IPS 102.

Anatomical features of CP angle cistern 138 provide a large extent ofunobstructed, CSF-filled subarachnoid space to accommodate a penetratingelement and shunt distal anchoring mechanism as further describedherein. FIG. 2C shows a portion of CP angle cistern 138 and the relativeproximity of the cistern to a patient's right IPS 102R and left IPS102L. Beyond the lateral boundaries of the cistern depicted in thefigure, the CSF filled subarachnoid space continues circumferentiallyaround the base of the skull, albeit with a lesser extent of CSF spacethan in CP angle cistern 138. CP angle cistern 138 comprises a depth offree CSF space labelled D1 in FIG. 2C between the skull base andbrainstem (not shown, but, e.g., between the anterior portions of theoccipital and spehnoid bones and the brain stem). CP angle cistern 138also comprises a height of free CSF space labelled H1 in FIG. 2C thatextends superiorly along the base of the skull (not shown, but extendingsuperiorly from the jugular foramen). CP angle cistern 138 furthercomprises a width extent of free space labelled W1 in FIG. 2C (e.g.,extent of free CSF space extending laterally between the right and leftjugular foramina, not depicted). CP angle cistern 138 contains arelatively large volume of CSF, as defined by the exemplary depth D1,height H1, and width W1 dimensions. FIG. 2D shows an alternative view ofthe same patient anatomy depicted in FIG. 2C, albeit with the D1 cisterndimension portions of left IPS 102L obscured by the view.

As shown in FIGS. 1 and 2C, most patients have two IPS 102 and twojugular veins 106 (left and right). In a very small percentage ofpatients (e.g., less than 1%), there is no connection between one IPSand the corresponding jugular vein. It is highly unlikely, however, thatany given patient will lack connections to the corresponding jugularveins on both left and right IPS.

Subarachnoid spaces are naturally occurring separations between the piamater and the arachnoid layer where the CSF pools. Typically, the CSF ispassed into a subarachnoid space over the cerebral hemispheres and theninto the venous system by arachnoid granulations. The subarachnoid space116 in FIG. 2A corresponds to a cerebellopontine (CP) angle cistern 138,which acts as a reservoir for CSF. In patients with hydrocephalus, abuild-up of CSF within the CP angle cistern 138 (in addition to othercisterns and the brain ventricles) can occur, for example, if patientslack properly functioning arachnoid granulations. If the excess CSF isnot removed, the resulting excess intracranial pressure can lead tosymptoms such as headache, neurological dysfunction, coma, and evendeath.

FIGS. 3A-J illustrates exemplary anchor 700, according to theembodiments of the disclosed inventions. The anchor 700 comprises aproximal portion 740, a middle or body portion 730, a distal portion 720(FIG. 3A), and a lumen 750 extending therebetween (FIG. 3A-B). Theproximal portion 740 of FIGS. 3A, 3C, 3E, 3F includes a beveled ortapered proximal section 742. The anchor 700 further comprises anelongate guide member 780 coupled to the proximal portion 740 and/orbeveled/tapered proximal section 742. As shown in FIGS. 3A, 3C and 3F,the beveled/tapered proximal section 742 is offset, as the tapertransitions to the bottom of proximal portion 740 and the elongate guidemember 780. Alternatively, the beveled/tapered proximal section 742 maybe symmetrical having the elongate guide member 780 centrally disposed,as shown in FIGS. 3E and 3H. Additionally, the distal portion 720 of theanchor 700 may include a beveled/tapered distal section 742, as shown inFIG. 3F. The proximal portion 740 and distal portion 720 of the anchor700 may taper at a variety of suitable angles. The proximal portion 740of the anchor 700 may comprise a strut or plurality of struts 712directly or indirectly coupled to the elongate guide member 780 (e.g.,FIG. 3E, 3H). In an alternative embodiment, the anchor 700 proximalportion 740 and distal portion 720 terminates at approximately 90° angle(i.e., without tapering), as shown in FIG. 3G.

The anchor 700 may be composed of suitable materials, such as, platinum,Nitinol®, gold or other biocompatible metal and/or polymeric materials,for example, silicon, or combinations thereof. In some embodiments, theanchor 700 may include materials that are compatible with magneticresonance imaging and have radiopacity sufficient to allow the use ofknown imaging techniques. In some embodiments, the anchor 700 iscomposed of shape memory, self-expandable and biocompatible materials,such as Nitinol®, or other super-elastic alloys, stainless steel, orcobalt chromium, and comprises a stent-like configuration. In otherembodiments, the anchor 700 may include other suitable configurations,such as tubular prosthesis, flow diverter, clot retriever, or the like.Alternatively, the anchor 700 can be composed of magnesium, zinc, orother bio-absorbable or dissolvable components.

The anchor 700 may be formed by laser cutting a flat sheet, a tubularmember, or other suitable configuration of the described materials intointerconnected struts 712 forming an open or closed cell pattern havinga plurality of cells 714, as shown by the closed cell patterns in FIGS.3A and 3C-H. Detailed portions of exemplary closed cell patterns of theanchor 700 having the plurality of struts 712 defining the plurality ofcells 714 are shown in FIGS. 3I-J. Other suitable techniques may be usedto form the closed (or open) cell pattern of the anchor 700, such asetching, or having a plurality of wires braided, woven, or coupledtogether (not shown). The anchor 700 further comprises a radiallycollapsed or delivery configuration and, a radially expanded or deployedconfiguration. In the deployed configuration the anchor 700 isconfigured to radially expand and anchor itself within the IPS 102 or CS104. The anchor 700 may include a length L₁ of approximately 2 mm toapproximately 20 mm, in the radially expanded configuration (FIG. 3C).The anchor 700 may include an outer diameter OD₁ of approximately 2 mmto approximately 6 mm or larger, in the radially expanded configuration(FIG. 3D). The anchor 700 is radially compressible about the axis 751 ofthe lumen 750, and configured to collapse within a delivery catheter(e.g., a delivery catheter having an inner diameter of approximately0.014″ to approximately 0.040″) such that a clinician can navigate thecollapsed anchor 700 through one or more catheters into the IPS 102 orCS 104.

The anchor 700 and the elongate guide member 780 coupled to the proximalportion 740 of the anchor 700 can be manufactured from the same piece ofmaterial (e.g., a super-elastic alloy such as Nitinol®), or may compriseseparate parts joined at a joint 744 between anchor 700 and the elongateguide member 780. As shown in FIGS. 3A, 3C, 3E-H, the elongate guidemember 780 is coupled (e.g., directly or indirectly, attached, secured,joined, or their like) to the proximal portion 740 of the anchor 700.Alternatively, the elongate guide member 780 can be coupled to thedistal portion 720, middle portion 730, and/or to any strut or pluralityof struts 712 (FIG. 3E, 3H) of the anchor 700 (not shown). The elongateguide member 780 can have a flat, rectangular, or otherwisenon-circular, cross-sectional profile, as shown for example in FIG. 3Dand FIG. 11. By way of non-limiting example, the elongate guide member780 can have a rectangular cross-sectional profile with dimensions ofapproximately 0.001″×0.003″ to 0.008″×0.040″. An elongate guide member780 with rectangular cross-sectional profile can provide increasedcolumn strength to facilitate navigation of the anchor 700 through adelivery catheter to a target location in IPS 102 or CS 104 and, ifnecessary, to assist with the re-sheathing of the anchor 700 into adelivery catheter for re-deployment of the anchor 700 prior topenetration of the IPS wall 114/arachnoid layer 115 and deployment ofthe shunt, or when removing the anchor 700 from the patient'svasculature after the deployment of the shunt. When used with thedelivery catheter 3304 including a dedicated lumen 3315 configured toconform to the rectangular cross-sectional profile of the guide member780 (e.g., as shown in FIG. 10), the elongate guide member 780 maintainsthe trajectory of the delivery catheter 3304 over the guide member andat the target penetration site by limiting or preventing rotation of thedelivery catheter 3304 about or around the guide member 780.

Alternatively, embodiments of elongate guide member 780 can have acircular cross-sectional profile, as shown in FIGS. 17A-C. By way ofnon-limiting example, an elongate guide member 780 with circularcross-sectional profile can have a diameter of about 0.005″ to 0.018″ ormore. The elongate guide member 780 having a tubular configuration mayinclude a plurality of cuts to increase flexibility, as shown by theexemplary spiral cut pattern of kerf, pitch, cuts per rotation and cutbalance depicted in sections of FIGS. 17A-C. Such configurations of theelongate guide member can improve the “trackability” of a deliverycatheter over the guide member (e.g., a delivery catheter with adedicated lumen configured to conform to the guide member profile), andprovide the ability to radially orient the delivery catheter andpenetrating element about the guide member in the lumen of IPS 102 or CS104. An elongate guide member 780 with circular cross-sectional profilecan provide increased column strength to facilitate navigation of theanchor 700 through a delivery catheter to a target location in IPS 102or CS 104 and, if necessary, to assist with the re-sheathing of theanchor 700 into a delivery catheter for re-deployment of the anchor 700prior to penetration of the IPS wall 114/arachnoid layer 115 anddeployment of the shunt, or when removing the anchor 700 from thepatient's vasculature after the deployment of the shunt. Further, theability to radially orient the delivery catheter and penetrating elementabout the guide member in the lumen of IPS 102 or CS 104 can be used tocorrect the orientation of a mis-loaded delivery catheter over the guidemember.

The profile, dimensions, and material for the elongate guide member 780are configured to resist kinking along the length of the elongate guidemember 780 and provide sufficient column strength for anchor deploymentand re-sheathing, while still allowing sufficient flexibility fordeployment through a delivery catheter by tracking through the curvedportion of the IPS 102. Alternatively, the elongate guide member 780 canhave a pre-curved distal portion, disposed closer to the joint 744between anchor 700 and the elongate guide member 780, so as to bias theelongate guide member 780 towards IPS wall 114 or IPS wall 117 when theelongate guide member 780 is deployed through the curved portion of theIPS 102. Further, the joint 744 between the anchor 700 and the elongateguide member 780 may include a rotatable element (FIGS. 18E-F) allowingthe elongate guide member 780 to assume a desirable orientation throughthe curved portion of the IPS 102.

Radiopaque markings or coatings can be incorporated into the anchor 700and/or elongate guide member 780 to assist with navigation anddeployment of the anchor 700 in a sinus lumen distal to a targetpenetration site on IPS wall 114. The radiopaque markings may be placedon one or more of the following locations along the anchor 700 andelongate guide member 780, as shown in FIG. 3C: in a plurality of struts712 at the distal portion 720 of the anchor 700; along L₁, with orwithout rotationally varying marker placement along the middle or bodyportion 730 of the anchor 700 to further aid navigation and orientation;at the joint 744 between anchor 700 and the elongate guide member 780,and/or on or around the first full-diameter portion of anchor 700 at theproximal portion 740.

FIGS. 4A-C illustrate another exemplary anchor 700, constructedaccording to embodiments of the disclosed inventions. FIG. 4A-B depictrespective side views, and FIG. 4C depicts a cross-sectional view of theanchor 700, comprising a plurality of cuts 710 forming a stent-likeconfiguration, having a plurality of struts 712. The anchor 700, theelongate guide member 780, cuts 710 and/or the patterns of the cuts 710may be manufactured by selectively cutting a tubular element using anysuitable cutting method (e.g., laser cutting, etching or their like).FIGS. 5A-W depicts exemplary dimensions and cut patterns of the anchor700, constructed according to embodiments of the disclosed inventions.The struts 712 of the anchor 700 form a plurality of spaces or cells 714therebetween. The cells 714 include a closed cell pattern when theanchor 700 is in the radially expanded configuration, as for exampleshown in FIGS. 3E, 3H-J, 5O and 5U, and a closed cell pattern when theanchor 700 is in the radially compressed configuration, as for exampleshown in FIGS. 4A, 5G, and 5K. In one embodiment of the anchor 700, thecut pattern shown in the radially compressed configuration in FIG. 5G,is configured to form the radially expanded configuration of the anchor700 shown in FIG. 5O. FIGS. 5P-T illustrate exemplary dimensions andproperties of the anchor 700 of FIGS. 5G and 5O, such as the variationsof the beveled/tapered proximal portions 740. Varying the taper in theproximal portion 740 (e.g., as described by the transition lengthmeasurements of FIG. 5T) can facilitate smooth anchor deployment andretrieval when paired with an appropriately sized catheter (e.g.,catheter with 0.027″ inner diameter). In an alternative embodiment ofthe anchor, the cut pattern shown in the radially compressedconfiguration in FIG. 5K, is configured to form the radially expandedconfiguration of the anchor 700 shown in FIG. 5U. FIGS. 5V-W illustrateexemplary dimensions and properties of another embodiment of anchor 700of FIG. 5U, such as having beveled/tapered proximal portion 740 anddistal portion 720. The beveled/tapered distal portion 720 of anchor 700depicted in FIG. 5U, and corresponding flexibility provided by thespiral cut pattern of such distal portion shown in FIG. 5K, facilitatesaccess to remote, narrowing, and/or tortuous regions of the intracranialvenous anatomy such as IPS 102 and CS 104. For illustration purposes,FIGS. 5P-S and 5V-W are depicted without the struts 712 and cells 714 ofthe anchor 700 to better appreciate the dimensions and properties of theanchor 700 in said figures (in a radially expanded configuration).However, it should be appreciated that the anchor 700 of FIGS. 5P-S and5V-W includes the struts 712 and cells 714 of their respective FIGS. 5Oand 5U The struts 712 and cells 714 of the anchor 700 substantiallyextend along the length L₁, as for example shown in FIG. 3C in theradially expanded configuration, and in FIG. 5G in the radiallycompressed configuration. However, the struts 712 and cells 714 mayextend along selected portions of the anchor 700, as for example shownin FIG. 5U at the distal portion 720. Additionally, the anchor 700 caninclude a mesh framework between the struts 712 to increase the frictionbetween the anchor 700 and IPS 102 (or CS 104), further securing theanchor 700 at or about the target site when deployed. The struts 712 ofanchor 700 can have flat, round, elliptical, or irregularly shapedprofiles or suitable cross-sections. The width of the struts 712 canvary from approximately 0.0030″ to 0.0045″, or larger. Additionally, thestruts 712 can be configured to exhibit a negative Poisson's ratio understrain such that, after deployment in a sinus lumen (e.g., IPS 102 or CS104), applying a retrograde force to anchor 700 (e.g., by pullingproximally on the anchor 700 via the elongate guide member 780) furtherexpands the struts 712 radially outward to secure the anchor 700 at thetarget site.

Dimensions referenced in FIGS. 5A-5W in brackets (e.g., [14.67]) areprovided in millimeters, while all other dimensions referred withoutbrackets are provided in inches. It should be appreciated that thedimensions depicted in FIGS. 4A-5W are exemplary dimensions of theanchor 700, which are not intended to limit the embodiment of the anchor700 disclosed herein.

FIG. 6 is a side view of a delivery assembly 300 for delivering theanchor 700 and the shunt into a target site of a patient, constructed inaccordance with embodiments of the disclosed inventions. The deliveryassembly 300 includes the anchor 700 and the shunt (not shown)detachably coupled to the delivery assembly 300. The delivery assembly300 and the shunt may be composed of suitable biocompatible materials.The delivery assembly 300 is dimensioned to reach remote locations ofthe vasculature and is configured to deliver the anchor 700 and theshunt percutaneously to the target location (e.g., inferior petrosalsinus). The delivery assembly 300 includes a tubular member interfacehaving an outer tubular member 320 (i.e., guide catheter) and an innertubular member 304 (i.e., delivery catheter/micro catheter) coaxiallydisposed within the outer tubular member 320 and movable relative to theouter tubular member 320. The delivery assembly 300 may include aguidewire 302 coaxially disposed within the guide catheter 320 and/orthe delivery catheter 304. The guidewire 302 can be, for example, 0.035″(0.889 mm) in diameter. Additionally to the guidewire 302, the deliveryassembly 300 may include a delivery guidewire 308 disposed within thedelivery catheter 304. The delivery guidewire 308 has a smaller diameter(e.g., approximately 0.010″ (0.254 mm) to 0.018″ (0.4572 mm) or othersuitable dimension to facilitate accessing intracranial venousvasculature with other components of delivery assembly 300) compared toguidewire 302.

The guide catheter 320, delivery catheter 304, and guidewires 302/308(FIG. 6) may be formed of suitable biocompatible materials, and mayinclude markings 13 for purposes of imaging (e.g., markers composed ofradio-opaque materials). Various known and often necessary accessoriesto the delivery assembly 300, e.g., one or more radiopaque marker bands13 at the distal portion 324 of the guide catheter 320 to allow viewingof the position of the distal portion under fluoroscopy and a Luerassembly 17 for guidewires and/or fluids access, are shown in FIG. 6.The delivery assembly 300 and/or the shunt may include a penetratingelement (not shown) configured to pierce and/or penetrate the IPS wall114 and arachnoid layer 115 to access the CP angle cistern 138 forimplantation of the shunt 200.

FIGS. 7A-F illustrate exemplary methods of delivering the anchor 700,the elongate guide member 780 and the shunt 200 at a target site,according embodiments of the disclosed inventions. The anchor 700 isconfigured to be deployed and disposed within the IPS 102 or the CS 104prior to penetration of the IPS wall 114 and deployment of a shunt. Insome embodiments, the anchor 700 is configured to be distally disposedto a target penetration site in IPS wall 114, as to provide support(e.g., foundation) for subsequent IPS wall 114 penetration, and shuntdeployment steps of the implant procedure. The anchor 700 may bedeployed in the IPS 102 or CS 104 by advancing the anchor 700 out of thedistal end opening of the delivery catheter 304, or by withdrawing thedelivery catheter 304, and/or by a combination of advancing the anchor700 and withdrawing the catheter 304 for deployment of the anchor 700 inthe IPS 102 or CS 104 (not shown).

When the anchor 700 is deployed into the target site (e.g., IPS 102 orCS 104), the anchor 700 transitions from its delivery configuration(e.g., radially constrained by an inner lumen of the delivery catheter304) to its deployed configuration (e.g., expanding radially outwards,so as to engage the walls of the IPS 102 or CS lumen 131). When deployed(FIG. 7A), the struts 712 of the anchor 700 are biased to exert anoutward radial force that engages and secures the anchor 700 within theIPS 102, against IPS walls 114 and 117, or against the equivalent wallsof the CS 104. The ratio of the resting anchor 700 diameter (i.e.,expanded, unconstrained configuration) to the reference vessel diameter(i.e., diameter of the sinus lumen where the anchor will be deployed)can range from about 1:1 up to about 2:1. In addition, the exteriorsurface of anchor 700 can include anchoring elements, spikes, burrs,barbs or other features to engage the dura mater of IPS walls 114 and117 (or the walls of CS lumen 131), which further secures the anchor inIPS 102 or CS 104.

The delivery catheter 304, with or without a delivery guide wire,facilitates navigation and delivery of the anchor 700 within thepatient's vasculature through the junction 118 and into the IPS 102and/or CS 104. The compressible nature of the anchor 700 allows theclinician to deploy the anchor 700 from the delivery catheter 304 withinthe IPS 102 (or CS 104), re-sheath the anchor 700 into the deliverycatheter 304 (when needed), and redeploy the anchor 700 within theapplicable sinus lumen (e.g. IPS 102 and/or CS 104) until the clinicianis satisfied with the deployment location and orientation of the anchor700 and/or elongate guide member 780 in the patient.

As shown in FIG. 7A, the anchor 700 is deployed in the IPS 102. Theanchor 700 is disposed in the IPS 102 distal to a target penetrationsite in IPS wall 114. The elongate guide member 780 coupled to theanchor 700 extends from the IPS 102 through the curved portion of IPS102 into the junction 118. The elongate guide member 780 further extendsinto the jugular vein 106, and can extend further through venousvasculature and out of the patient's body at the peripheral access site(e.g., femoral vein). The delivery catheter 304 used to deploy theanchor 700 may be withdrawn from the patient to allow for other deliverysystem components to access the IPS 102 after deployment of the anchor.Alternatively, the delivery catheter 304 used to deploy the anchor 700may allow further deployment of other components (e.g., piercing orpenetrating elements, shunts, or their like) into the IPS 102 withoutneeding withdrawal of the delivery catheter 304 for other deliverysystems. As previously disclosed, the anchor 700 can be deployed in amore distal location, such as CS 104.

The shunt 200 capitalizes on a favorable pressure gradient between thesubarachnoid space 116 (e.g., CP angle cistern 138) and venous system(e.g., IPS 102, jugular vein 106, and/or a jugular bulb 108) to driveCSF through the shunt 200 (i.e., inner lumen). In patients withouthydrocephalus, the normal differential pressure between the intracranialpressure of the subarachnoid space 116 and blood pressure of the venoussystem is about 5 to 12 cm H₂O; this differential pressure between thesubarachnoid space and venous system can be significantly higher inhydrocephalic patients. Once deployed and implanted, the shunt 200facilitates one-way flow of CSF from the subarachnoid space 116 into thejugular the bulb 108 and/or jugular vein 106 where CSF is carried awayby venous circulation, similar to the way that normally functioningarachnoid granulations drain CSF into the venous system. The shunt 200prevents backflow of venous blood into subarachnoid space 116 via one ormore one-way valves or any other flow regulating mechanisms. The shunt200 allows for a more physiologic drainage of CSF by directing CSF intothe cerebral venous system, a process that occurs naturally in peoplewithout hydrocephalus. In this manner, the pressure created by theexcess CSF in the subarachnoid space 116 is relieved, and patientsymptoms due to hydrocephalus can thereby be ameliorated or eveneliminated. The shunt 200 of FIGS. 7E-F includes a valve 209 as the flowregulating mechanism configured to regulate fluid flow through the shunt200 into the venous system.

In embodiments of the inventions, a target flow rate of CSF (e.g., in arange of about 5 ml per hour to about 15 ml per hour) through the shunt200 at a normal differential pressure is defined as being in a rangebetween about 5 cm H₂O to about 12 cm H₂O between the subarachnoid space116 and venous system (e.g., jugular vein 106 and/or a jugular bulb108).

In some embodiments, a target flow rate of CSF through the shunt 200and/or valve 209 is approximately 10 ml per hour at a range ofdifferential pressure between the subarachnoid space 116 and venoussystem (“AP”) between 3 to 5 mmHg. A maximum flow rate of CSF throughthe shunt 200 and/or valve 209 can exceed 20 ml per hour and typicallyoccurs immediately after shunt implantation in a patient with elevatedICP (e.g., ICP greater than 20 cm H₂O). The valve 209, as the flowregulating mechanism of the shunt 200, comprises a normal operatingrange (CSF flow direction) of 0.5 to 8 mmHg AP, having a valve openingpressure (CSF flow direction) of approximately 0.5 mmHg AP, and areverse opening pressure (backflow prevention) of at least −115 mmHg AP.Additionally, the valve 209 may comprise an allowable CSF leakage (flowdirection) of less or equal to 0.5 ml per hour, and/or an allowableblood backflow (reverse direction) of less or equal to 0.25 ml per hour.

A positive pressure gradient between the intracranial pressure (ICP) ofthe subarachnoid space and the blood pressure of the venous system maycontribute to the natural absorption of CSF through arachnoidgranulations. ICP greater than 20 cm H20 is considered pathological ofhydrocephalus, although ICP in some forms of the disease can be lowerthan 20 cm H20. Venous blood pressure in the intracranial sinuses andjugular bulb and vein can range from about 4 cm H20 to about 11 cm H20in non-hydrocephalic patients, and can be slightly elevated in diseasedpatients. While posture changes in patients, e.g., from supine toupright, affect ICP and venous pressures, the positive pressure gradientbetween ICP and venous pressure remains relatively constant. Momentaryincreases in venous pressure greater than ICP, however, can temporarilydisturb this gradient, for example, during episodes of coughing,straining, or valsalva.

The shunt 200 and/or the valve 209 are configured to handle expectedacute and chronic differential pressures between the subarachnoid space116 and venous system (“AP”) when implanted in a patient. A maximum,acute negative AP occurs, for example, between a maximum venous pressure(VP) and a minimum intracranial pressure (ICP), such as, if the patientcoughs while moving from a supine to upright position. Embodiments ofthe valve 209 are configured to seal, shut and/or close under thenegative AP conditions (i.e., when venous pressure exceeds intracranialpressure), preventing venous blood from flowing back through the shunt200 into the subarachnoid space 116. A maximum, acute positive APoccurs, for example, between a maximum ICP and a minimum VP, such as theacute positive AP caused by coughing when the patient transitions froman upright to supine position. Additionally, the shunt 200 and/or thevalve 209 are configured to handle chronic elevated, positive APconditions (e.g., approximately two or more minutes of elevated positiveΔP, such as between maximum hydrocephalus ICP and normal VP [e.g.,hydrocephalus with low expected VP]); and to handle chronic, elevatednegative AP conditions (e.g., approximately two or more minutes ofnegative AP, such as between minimum ICP and maximum VP [e.g.,supine→upright posture change with minimal VP adjustment]).

In some embodiments, a delivery catheter 3304 can include one or morefeatures that allow for accurate guidance, navigation and/or control ofthe deployment of the penetrating element and/or the shunt, particularlywhen passing through the junction 118 into the IPS 102. FIGS. 8A-Billustrate perspective and cross-sectional views of the deliverycatheter 3304, according to one embodiment of the disclosed inventions.The delivery catheter 3304 comprises a recess 3313 formed in the outersurface 3310 of the catheter. The recess 3313 is configured to slidablyengage the elongate guide member 780 of the anchor 700, so that thedelivery catheter 3304 rides on the elongate guide member 780 of thepreviously deployed anchor 700 (e.g., “side car” configuration),allowing the catheter 3304 to be guided in a desired orientation andlocation within the target site in the IPS 102, as shown in FIG. 7B. Theelongate guide member 780 is dimensioned and configured to engage therecess 3313 in the delivery catheter 3304. The elongate guide member 780is further configured to guide the delivery catheter 3304 into thetarget penetration site, as shown in FIGS. 7B and 7D. The embodimentshown in FIGS. 8A-B is an exemplary control feature that can beimplemented in connection with the catheter 3304. In some embodiments,the catheter 3304 and anchor 700 can include a plurality of suchfeatures (e.g., a plurality of elongate guide members that engage with aplurality of recesses).

As shown in FIG. 7B, the delivery catheter 3304 has been advanced over,in or on the elongate guide member 780 of the previously deployed anchor700. Alternatively to the recess 3313 disclosed above, the deliverycatheter 3304 can have a dedicated lumen 3315 extending between thedelivery catheter proximal and distal portions configured to accommodatethe elongate guide member 780 of the anchor 700. Alternatively, thedelivery catheter 3304 can include a broken or incomplete lumenextending between the proximal and distal portions of the catheter thatcaptures the elongate guide member 780 against IPS wall 117 and allowsthe catheter to travel over the elongate guide member 780. At least oneother lumen 3305 of delivery catheter 3304 extends between the proximaland distal portions of the catheter 3304 (FIGS. 8A-B, and FIG. 9), whichallows for navigation and delivery of the penetrating elements (e.g.,surgical tool, needles, RF stylets, or the like) and shunt devices, withor without penetrating distal tip disclosed herein, and in the relatedapplication previously incorporated by reference herewith. The distalportion 3344 of the delivery catheter 3304 intersects the IPS wall 114at an angle of approximately 75° (or any other suitable angle) at thetarget penetration site, as shown in FIG. 7B.

FIGS. 10A-K depict additional embodiments of a dual lumen deliverycatheter 3304. As shown in FIGS. 10A-E, a distal portion 3344 of thedelivery catheter includes a penetrating element 3350. Each catheter ofFIG. 10 includes a first lumen 3315 extending between the ends of thecatheter, which is configured to receive the elongate guide member 780and, optionally, conforms to the profile of the elongate guide member. Asecond lumen 3305 of the foregoing catheter embodiments extends betweenthe ends of the catheter, which allows for navigation and delivery ofthe penetrating elements (e.g., surgical tool, needles, RF stylets, ortheir like) and shunt devices with or without penetrating distal tipdisclosed herein, and in the related application previously incorporatedby reference herewith. Further, one or both lumens of delivery catheter3304 shown in FIGS. 10A-K can include a liner and/or can be coated witha hydrophilic agent to increase the lubricity of such lumens withrespect to other delivery assembly components as described in therelated application previously incorporated by reference herewith. FIGS.10B, 10D, and 10E-J show elongate guide member 780 disposed within firstlumen 3315, and FIGS. 10B, 10E-J show the shunt 200 with a hollow innerlumen 207 disposed within second lumen 3305 for the exemplary deliverycatheter 3304 embodiments. It should be appreciated that the dimensionsdepicted in 10A-K are exemplary dimensions of the delivery catheter3304, first lumen 3315, second lumen 3305, penetrating element 3350,shunt 200, and shunt lumen 207, which are not intended to limit thescope of embodiments disclosed herein. For example, embodiments ofdelivery catheter 3304 can have a second lumen 3305 with an innerdiameter in a range of about 0.012″ (0.3048 mm) to 0.040″ (1.016 mm) ormore.

The anchor 700 and the elongate guide member 780 can be optimized toorient the penetrating element or shunt advancing via the catheter 3304over the elongate guide member 780 towards a target penetration site onthe IPS wall 114 along the curved portion of IPS 102. For example, theelongate guide member 780 coupled to the anchor 700 at a location alongthe top edge of anchor 700, is configured to orient a distal portion 782of the elongate guide member 780 proximate or adjacent to the IPS wall114, as shown in FIGS. 7A-B. Alternatively, the anchor 700 and theelongate guide member 780 can be configured such that the elongate guidemember 780 orients (e.g., “hugs”) nearest the IPS wall 117 through thecurved portion of IPS 102, as shown in FIGS. 7C-D, when the anchor 700is deployed distally to a target penetration site along the IPS wall114.

Additionally, the deployment location of the anchor 700 in the sinuslumen can vary the path of the elongate guide member 780 through thecurved portion of IPS 102, regardless of how the elongate guide member780 is oriented with respect to the top, midline, or bottom portions ofthe anchor 700. For example, deploying the anchor 700 more distally thanthe deployment location shown in FIGS. 7A-B will orient the elongateguide member 780 more proximate to the IPS wall 117 than IPS wall 114.

Additionally, embodiments of the delivery catheter 3304 (or a shunt ifdelivered over the elongate guide member 780 without a deliverycatheter) can be optimized to orient a penetrating element and/or shuntadvancing through or over the elongate guide member 780 towards a targetpenetration site in the IPS wall 114 along the curved portion of IPS102. The distal portion 3344 of the delivery catheter 3304 can havemultiple interface points to accommodate the elongate guide member 780,as denoted by the “x” markings in FIG. 7D. The interface point on thedistal portion 3344 of delivery catheter 3304 for the elongate guidemember 780 provides a penetration stop to limit the distance thepenetrating element 3350 can travel through IPS wall 114 and into CPangle cistern 138 (e.g., the maximum penetration depth corresponds tothe distance between the distal tip of penetrating element 3350 and theinterface point on delivery catheter 3304 for receiving elongate guidemember 780). Introducing the elongate guide member 780 into or along thedelivery catheter 3304 at a more proximal location on the catheter 3304allows for more separation between the penetrating element 3350 and/or adistal open end 3341 of the delivery catheter 3304 and the elongateguide member 780. The greater extent of separation between thepenetrating element 3350 and elongate guide member 780 provides arelatively longer depth of penetration through IPS wall 114 andarachnoid layer 115 along the curved portion of IPS 102. Conversely, amore distal entrance point or connection along the delivery catheter3304 and the elongate guide member 780 decreases the separation betweenthe elongate guide member 780 and the penetrating element 3350 and/ordistal open end 3341 of delivery catheter 3304. The lesser extent ofseparation between the penetrating element 3350 and elongate guidemember 780 provides a relatively shorter depth of penetration throughIPS wall 114 and arachnoid layer 115 along the curved portion of IPS102. A clinician can adjust the interface point between the elongateguide member 780 and delivery catheter 3304 to optimize the trajectoryof a penetrating element from the delivery catheter 3304 and penetrationdepth at a target penetration site along the IPS 114. The interfacepoint between the elongate guide member 780 and delivery catheter 3304can range from the distal end 3341 of delivery catheter 3304 (e.g.,where the distal end of the delivery catheter includes a distal openingto a dedicated rail lumen) to an interface point about 10 cm proximalfrom the distal end of delivery catheter 3304.

Once deployed, the anchor 700 and the elongate guide member 780 providea stable, intra-sinus platform that creates an off-axis trajectory forthe penetrating element during shunt implantation. The deployed anchor700 and elongate guide member 780, along with other aspects of thedelivery system, afford clinicians controlled access to the greatestextent of CSF-filled space in the CP angle cistern 138 during shuntdeployment. The elongate guide member 780 extending through the curvedportion of IPS 102 advantageously orients the penetrating element 3350(i.e., advancing via the guide member) toward IPS wall 114 into CP anglecistern 138. As shown in FIG. 7D, the portion of delivery catheter 3304distal of the interface point separates from the axis of the elongateguide member 780 as the delivery catheter advances over the guide memberthrough the curved portion of the IPS; that is, the distal most portionof delivery catheter 3304 including penetrating element 3350 traveloff-axis from elongate guide member 780 to puncture IPS wall 114 andaccess the CSF-filled CP angle cistern 138. This orienting feature ofthe elongate guide member with respect to delivery catheter 3304 ensuresthat advancement of the penetrating element will: (a) intersect the IPSwall 114 at a target penetration site along the curved portion of IPS102 at an angle of approximately 90° (i.e., oriented orthogonal to IPSwall 114) to approximately 30° (although, other suitable angles may beprovided), and (b) continue on a trajectory through the dura mater ofthe IPS wall 114 and through the arachnoid layer 115 to access at least2-3 mm of unobstructed, CSF-filled space of CP angle cistern 138 asmeasured distally from the penetration point on the IPS wall 114.Features of anchor 700 and the elongate guide member 780 disclosedherein allow clinicians to access and deploy a shunt in a relativelylarger extent of free CSF-filled space in the cistern, often more than 3mm to 5 mm of unobstructed CSF-filled space, compared to otherendovascular shunt delivery techniques.

After the anchor 700 and the elongate guide member 780 have beendeployed at a desired location in the sinus lumen and the penetratingelement has been advanced over the elongate guide member 780 to a targetpenetration site along the IPS wall 114, the clinician can proceed bycreating anastomosis between the IPS 102 and the CP angle cistern 138,followed by the shunt delivery and implantation steps of procedure. Theclinician can penetrate the IPS wall 114 to access the CP angle cistern138 with the penetrating element (e.g., penetrating element advanced viathe catheter, on the shunt, or carried by the catheter distal end) bypulling the elongate guide member 780 in the proximal direction (orlocking the elongate guide member 780 in place relative to otherdelivery system components) while advancing the penetrating element overthe elongate guide member 780, toward the IPS wall 114. The retrogradeforce on the elongate guide member 780 during the penetration stepfurther secures the guide member and anchor 700 in the sinus lumen,thereby stabilizing the elongate guide member 780 in the curved portionof the IPS 102 while it orients a penetrating element towards IPS wall114 and off-axis from the trajectory of elongate guide member 780 in thecurved portion of the IPS lumen. And by simultaneously advancing thepenetrating element and/or shunt 200 (as previously disclosed) throughthe IPS wall 114 and arachnoid layer 115 until a distal anchoringmechanism 229 of the shunt 200 is deployed in the CP angle cistern 138(i.e., without an exchange of delivery system components between thepenetration and shunt deployment steps) eliminates the risk of bleedingfrom the sinus lumen into the subarachnoid space.

Radiopaque markings or coatings can be incorporated on the penetratingelement 3350 (e.g., penetrating element advanced via the catheter, onthe shunt, or carried by the distal end of the delivery catheter) and/orthe delivery catheter to assist the clinician visualize the orientationof delivery system elements in the sinus lumen and the trajectory ofsuch elements prior to or during the penetration step of the shuntimplant procedure. For example, a semi-circle piece or half-band ofradiopaque material can be coupled to or incorporated within thepenetrating element 3350 and/or in the distal portion 3344 of thedelivery catheter 3304. Depending on the location of the marker in thepenetrating element 3350 and/or distal portion 3344 of the deliverycatheter 3304 (e.g., distal section or proximal section of thepenetrating element to assist with the visualization of the respectivesection of the inner diameter or lumen), the clinician can confirmwhether the penetrating element 3350 is properly oriented toward the IPSwall 114 and/or improperly oriented toward the IPS wall 117.

After the distal anchoring mechanism 229 of the shunt 200 has beendeployed in the CP angle cistern 138, the delivery catheter 3304 can bewithdrawn (i.e., pull in the proximal direction) from the curved portionof IPS 102. The distally anchored shunt 200 emerges from the distal endopening 3341 of the delivery catheter 3304 as the catheter is withdrawnthrough the IPS 102 into the junction 118; the distal anchoringmechanism of the shunt disposed within the CP angle cistern 138 retains,secures and/or anchors the shunt in its deployed location within thesubarachnoid space 116 as the delivery catheter 3304 is withdrawn fromthe IPS 102. Thereafter, the delivery catheter 3304 can be furtherwithdrawn through the junction 118 to allow the proximal anchoringmechanism 227 of shunt 200 to be deployed in the jugular vein 106, asshown in FIG. 7E.

After the shunt 200 has been fully deployed and/or secured at the targetsite by the shunt 200 respective anchoring mechanisms 227, 229, theclinician can advance the delivery catheter 3304 and/or a micro catheter(e.g., catheter having an inner diameter of 0.027″ or 0.021″) over theelongate guide member 780 to re-sheath the anchor 700, and then withdrawthe catheter 3304 containing anchor 700 and elongate guide member 780from the patient (e.g., via a femoral access point). Alternatively, theelongate guide member 780 can include an electrolytic detachment element785 in or around the joint 744 with anchor 700 (FIGS. 3C, 3H) or at anyother suitable portion of the elongate guide member 780 (e.g., FIG. 7F),so as to detach the elongate guide member 780 from the anchor 700. Afterdetachment of the elongate guide member 780 from the anchor 700, theelongate guide member 780 can be withdrawn from the patient while anchor700 remains deployed in the IPS 102 or CS 104. This configuration can beadvantageous to avoid accidental pullout of an implanted shunt from CPangle cistern 138 while retrieving the anchor 700 from its distaldeployment location by snagging the anchor 700 on a portion of thedeployed shunt, as the anchor 700 is withdrawn through the IPS 102 andthe junction 118.

In further alternative embodiments, the electrolytic detachment element785 can be proximately disposed from the joint 744 (e.g., at theelongate guide member 780 portion configured to be disposed around thejunction 118), as shown in FIGS. 7E and 7F. The anchor 700 and a portionof the elongate guide member 780 can be part of the implanted shuntingsystem where a deployed shunt includes one or more connection points orinterfaces with the elongate guide member 780, allowing the deployedanchor 700 and portion of the elongate guide member 780 to furtheranchor the shunt at its deployed location. In such embodiments, theelongate guide member 780 can include the electrolytic detachmentelement 785 at a portion of the elongate guide member 780 configured tobe disposed around the junction 118. So that, a proximal portion 780′(i.e., proximately to the electrolytic detachment element 785) of theelongate guide member 780 is withdrawn from the patient after deploymentof the shunt, while the distal portion of the elongate guide member 780remains coupled to the anchor 700. In this embodiment, the anchor 700may further provide a scaffold support for the deployed shunt 200, asshown in FIG. 7F.

The anchor 700 and the elongate guide member 780 system can have thefollowing advantages over other endovascular shunt delivery systems andtechniques:

Separate anchor 700 and shunt 200 deployment steps preserve criticalworking and deployment space in the IPS 102 and/or CS 104 around thetarget penetration site to accommodate delivery system components suchas delivery catheter 3304 and shunt 200 compared to a delivery systemconfigured for a single anchor and shunt 200 deployment step comprisingmultiple, concentric elements (e.g., a delivery catheter, deliverysystem anchor and/or guide wire, a shunt, and a penetrating element).

The anchor 700 and the elongate guide member 780 system provides astable platform to secure delivery system components during (a)penetration through the dura mater IPS wall 114 and arachnoid layer 115into CP angle cistern 138, and (b) deployment of the shunt distalanchoring mechanism 229 in the cistern compared to a conventionaldelivery catheter and guide wire system.

The anchor 700 and the elongate guide member 780 system resists“kickout” of delivery system components (e.g., delivery catheter 3304)from the IPS 102 and/or CS 104 into the jugular vein 106 resulting fromtortuous anatomy during critical procedure steps such as penetratingdura mater IPS wall 114 and arachnoid layer 115 and deploying the shuntand its distal anchoring mechanism 229.

In some embodiments of anchor 700, for example when the anchor is leftbehind in the sinus lumen (IPS 102 or CS 104) to secure that theimplanted shunt 200, the anchor can be configured for hydraulicexpansion using stainless steel or cobalt chromium materials, therebysimplifying system design and reducing product manufacturing costs.

The elongate guide member 780 extending proximally from a deployedanchor 700 along the IPS wall 117 eliminates or decreases the risk thatan uncovered or unprotected penetrating element inadvertently snags aportion of the IPS wall 114 as the penetrating element is delivery tothe target penetration site.

FIGS. 12A-F illustrate an alternative delivery catheter 1304 fordelivering a shunt into a target site of a patient, constructed inaccordance with embodiments of the disclosed inventions. For ease inillustration, the features, functions, and configurations of thedelivery catheter 1304 that are the same as in the delivery catheters304 and 3304 of the present disclosure and the delivery catheters 304,304′ in the related application previously incorporated by referenceherewith, are given the same reference numerals. The delivery catheter1304 comprises an elongated configuration having a proximal portion1342, a distal portion 1344 and a lumen 1341 extending therebetween. Thedelivery catheter 1304 is dimensioned to reach remote locations of thevasculature and is configured to deliver the shunt percutaneously to thetarget site (e.g., IPS, CS, CP angle cistern, or the like). The deliverycatheter 1304 comprises variable stiffness sections (e.g., varying ratioof material, including selective reinforcement, varying the propertiesor distribution of the materials used and/or varying the durometer orthickness of the materials during the process of manufacturing) suitableto provide sufficient “pushability” (e.g., exhibits sufficient columnstrength to enable delivery to target locations such as IPS 102 or CS104; in embodiments comprising a tissue penetrating element 1350,provides sufficient column strength to transmit about 0.1 N to 2.0 Nforce or more for the penetrating or piercing element to penetrate duraof IPS wall 114 and arachnoid layer 115) and “torqueability” (e.g., inthe vasculature exhibits a torque response of about 1:1 such that asingle clockwise turn of the catheter at the patient's groin or proximalportion results in approximately single clockwise turn of the distalportion of the catheter at a target location such as IPS 102 or CS 104)to allow the catheter 1304 to be inserted, advanced and/or rotated inthe vasculature to position the distal portion 1344 of the catheter atthe target site within the IPS 102 or CS 104. Further, the distalportion 1344 has sufficient flexibility so that it can track andmaneuver into the target site, particularly in tortuous anatomy.

Known components, such as embedded coils or braids, are often used toprovide selective reinforcement to delivery catheters. Deliverycatheters including embedded coils can provide suitable flexibility,however, the embedded coils usually fail to provide the necessary columnstrength for the catheter, particularly at the distal portion ofmicro-catheters. Delivery catheters including embedded braids canprovide with suitable column strength, while sacrificing flexibility,particularly if the embedded braids are disposed at the distal portionof the catheter.

In the embodiments of FIGS. 12A-C, the delivery catheter 1304 comprisesan reinforcing member 1345 configured to reinforce the catheter 1304while providing a suitable balance between column strength andflexibility (e.g., “pushability” and “torqueability”). The reinforcingmember 1345 is composed of suitable biocompatible and elastomericmaterials such as, stainless steel, Nitinol® or the like. In someembodiments, the reinforcing member 1345 comprises a stainless steel orNitinol hypotube providing suitable column strength, the hypotubefurther comprises selective cuts 1330, which provides suitableflexibility.

The reinforcing member 1345 may extend along a substantial length of thecatheter 1304 (e.g., the reinforcing member 1345 extends from theproximal portion 1342 to the distal portion 1344 of the catheter 1304).In the embodiment of FIG. 12A, length L₁₀, measured along a central axis1349 of the reinforcing member 1345 is approximately 59″ (150 cm).Alternatively, the reinforcing member 1345 can extend along a section ofthe catheter 1304 (e.g., the reinforcing member 1345 extends along thedistal portion 1344 without extending to the proximal portion 1342 ofthe catheter 1304). For example, L₁₀ can range between 1.9″ (5 cm) to 6″(15.2 cm), or any other suitable length.

Further, in the embodiment of FIGS. 12A-C, the inner diameter (ID) ofthe reinforcing member 1345 (e.g., lumen 1341) measured in a directionorthogonal to axis 1349 can range between 0.0205″ (0.5207 mm) to 0.024″(0.6096 mm), and the outer diameter (OD) of the reinforcing member 1345measured in the same direction (i.e., orthogonal to axis 1349) can rangebetween 0.026″ (0.6604 mm) to 0.03″ (0.762 mm). It should be appreciatedthat the ID, OD and/or the L₁₀ and any other length, width, or thicknessof the reinforcing member 1345 of the delivery catheter 1304 may haveany suitable dimension for delivering the shunt in the target site(e.g., IPS, CP angle cistern, or the like). Exemplary dimensions (ininches) and properties of the reinforcing member 1345 are shown in FIG.12G, which are not intended to limit the embodiment of FIGS. 12A-C.

In the embodiments of FIGS. 12A and 12C, the reinforcing member 1345comprises one or more cuts 1330 (e.g., kerfs, slots, key-ways, recesses,or the like) selectively disposed at the proximal portion 1342 and thedistal portion 1344 of the reinforcing member 1345. Additionally, theone or more cuts 1330 can be disposed in sections of the reinforcingmember 1345 along L₁₀, as shown by the exemplary spiral cut pattern ofkerf, pitch, cuts per rotation and cut balance depicted in sections ofFIG. 12A. Alternatively, the cuts 1330 can be continuously disposedsubstantially along L₁₀ (not shown), and the continuously disposed cuts1330 can have variable spiral cut patterns of kerf, pitch, cuts perrotation and cut balance along L₁₀ or combinations thereof.

The cuts 1330 of the reinforcing member 1345 can have a variety ofsuitable patterns, and can be manufactured by laser cutting thereinforcing member 1345 of the delivery catheter 1304. Alternatively,the cuts 1330 and their patterns can be manufactured by etching or othersuitable techniques. FIGS. 12E-F depict an exemplary cut pattern of thereinforcing member 1345 of FIGS. 12A-C. In these embodiments, the lasercutting of the reinforcing member 1345 creates between 1.5 to 2.5 cuts1330 per rotation of the reinforcing member 1345, having a cut balanceof between 100° to 202° of rotation with laser on, and then 34° to 38°of rotation with laser off.

As shown in FIG. 12A, the cuts 1330 of the reinforcing member 1345 thatare disposed at the proximal portion 1342 comprise a larger pitch (e.g.,0.015) than the pitch (e.g., 0.006) of the cuts 1330 disposed at thedistal portion 1344 of the reinforcing member 1345. The smaller thepitch of the cuts 1330 (i.e., smaller separation between cuts) providesfor an increase in flexibility of the reinforcing member 1345, such asat the distal portion 1344 of the delivery catheter 1304. The transitionbetween the larger pitch to the smaller pitch cuts 1330 can be subtle,providing for a progressively more flexible delivery catheter towardsthe distal portion. By way of non-limiting examples, the spiral cutpattern to create the cuts 1330 disposed at the proximal portion 1342 ofthe reinforcing member 1345 comprise a kerf of 0.001, a pitch of 0.015,creating 2.5 cuts per rotation, having a cut balance of 100° of rotationwith laser on, and then 34° rotation with laser off. The spiral cutpattern applied to create the cuts 1330 disposed between the proximalportion 1342 and the distal portion 1344 of the reinforcing member 1345comprises a kerf of 0.001, a pitch transition from 0.006 to 0.015,creating 1.5 cuts per rotation, having a cut balance of 202° of rotationwith laser on, and then 38° rotation with laser off. The spiral cutpattern applied to create the cuts 1330 disposed at the distal portion1344 of the reinforcing member 1345 comprises a kerf of 0.001, a pitchof 0.004, creating 1.5 cuts per rotation, having a cut balance of 202°of rotation with laser on, and then 38° rotation with laser off. Thecuts 1330 may have a width that ranges between 0.0005″ (0.0127 mm) to0.002″ (0.0508 mm), or any other suitable width. It should beappreciated that the width, length and depth of the cuts 1330 andpatterns of the cuts 1330 in the reinforcing member 1345 of the deliverycatheter 1304, can comprise any suitable dimensions. By way ofnon-limiting example, the pattern of cuts 1330 can transition to alarger pitch (e.g., greater than 0.004) in the distal portion 1344 ofreinforcing member 1345 to increase column strength and provide supportto a delivery catheter during the penetration step of the shunt implantprocedure.

Additionally, the reinforcing member 1345 comprises an inner liner 1360and an outer jacket 1365, as better seen in FIG. 12C. The inner liner1360 and outer jacket 1365 are composed of suitable implantablepolymeric materials, such as polytetrafluoroethylene “PTFE”,polyethyleneterephthalate “PET”, High Density Polyethylene “HDPE”,expanded polytetrafluoroethylene “ePTFE”, urethane, silicone, or thelike. The inner liner 1360 and outer jacket 1365 are configured tocover—completely or partially—the cuts 1330 of the reinforcing member1345, from within lumen 1341 and over the elongated member outer surface1370, respectively. In such configuration, the reinforcing member 1345becomes an impermeable tubular element having the cuts 1330 covered bythe respective inner liner 1360 and outer jacket 1365, while maintainingthe flexibility provided by the selective cuts 1330 and column strengthafforded, in part, by the reinforcing member 1345.

The inner liner 1360 provides a smooth inner surface in the lumen 1341of the reinforcing member 1345 that facilities translation and deliveryof the shunt (or other delivery systems or devices delivered through thelumen). Further, the inner liner 1360 can be configured to line theinterior reinforcing member 1345 using an extrusion process.Alternatively, the liner material can be deposited (e.g., using adispersion technique) on a mandrel (e.g., nickel coated copper);thereafter, the liner-coated mandrel can be placed within thereinforcing member 1345 for application of outer jacket 1365 andadhering the inner liner 1360 to the reinforcing member 1345, afterwhich the mandrel can be withdrawn from the reinforcing member 1345leaving inner liner 1360 in place within the lumen 1341 of thereinforcing member 1345.

The outer jacket 1365 provides a smooth outer surface to the reinforcingmember 1345, which facilitates the navigation of the delivery catheter1304 through tortuous vasculature. As noted above, the outer jacket 1365can comprise one or more implant-grade polymers including, but notlimited to, polyurethane or silicone-polyurethane blends. In someembodiments, a gas or liquid dispersion of polymer is applied to thereinforcing member 1345 and inner liner 1360, which forms the outerjacket 1365 and bonds the inner liner 1360, the reinforcing member 1345,and outer jacket 1365 together in an integrated configuration of thedelivery catheter 1304.

The outer jacket 214 can substantially cover the entire outer surface ofthe reinforcing member 1345; however, in some embodiments, the outerjacket can be placed selectively along sections of reinforcing member1345 to adhere the inner liner 1360 to the reinforcing member 1345. Byway of non-limiting example, a liquid dispersion of polymer or anepoxy-based adhesive can be placed at discrete locations along L₁₀.Alternatively, the outer surface of inner liner 1360 can be coated withpolymer or adhesive, and then placed within reinforcing member 1345; thepolymer or adhesive can seep into the cuts 1330, completely or partiallyfilling some or all of the cuts 1330 along L₁₀.

In the embodiment of FIG. 12C, the inner liner 1360 can have a thicknessof 0.0005″ (0.0127 mm); though the thickness of inner liner 1360 canrange from 0.0005″ (0.0127 mm) to 0.0015″ (0.0381 mm) in otherembodiments. In the embodiment of FIG. 12C, the outer jacket 1365 canhave a thickness of 0.001″ (0.0254 mm); though the thickness of outerjacket 1365 can range from 0.0001″ (0.00254 mm) to 0.001″ (0.0254 mm) inother embodiments. It should be appreciated that the inner liner 1360,and the outer jacket 1365 of the reinforcing member 1345 may compriseany suitable dimensions.

Referring back to FIG. 12A, the reinforcing member 1345 furthercomprises a penetrating element 1350 (e.g., sharp, tapered, cannula-likeend, bevel, pencil, or Quincke tip needle, or the like) extending ordisposed at the distal portion 1344 of the elongated member, as alsodepicted in FIG. 12D. The penetrating element 1350 is configured topenetrate the dura mater of the IPS wall 114 and the arachnoid layer 115creating an anastomosis between the IPS 102 and the CSF-filled CP anglecistern 138 for deployment of the shunt, as previously disclosed herein,and in the related application previously incorporated by referenceherewith. The cuts 1330 proximately disposed to the penetrating element1350 are configured to provide suitable flexibility to the distalportion 1344 of the delivery catheter 1304, allowing the distal portion1344 to bend, curve and/or orient the penetrating element 1350 towardsthe IPS wall 114, while maintaining suitable column strength to supportthe penetrating element 1350 at the distal portion 1344 as it penetratesthrough the IPS wall 114 and arachnoid layer 115. The penetratingelement 1350 extending from, integrated with and/or incorporated to thedistal portion 1344 of the reinforcing member 1345 allows for a securewithdrawal of the penetrating element 1350 when the delivery catheter1304 is withdrawn from the patient.

FIG. 13 illustrates an elongated pusher 3710, constructed in accordancewith embodiments of the disclosed inventions. The elongated pusher 3710comprises a support tubular member 3711, having a proximal portion 3712,a middle portion 3713 and a distal portion 3714, and a lumen 3724extending therebetween. The proximal portion 3712 of the support tubularmember 3711 is coupled to a handle 3722, which will be described infurther detail below. The pusher 3710 provides telescoping support to aguidewire or other interventional devices as a clinician translates suchguidewire or device through a catheter to a target site.

The elongated pusher 3710 is configured to translate (e.g., advance,push) interventional access/treatment devices (e.g., stent anchor 700,guide member 780, guidewires, thrombectomy devices, or the like) intothe IPS 102 or any other target site, through a catheter (e.g., deliverycatheter 304/3304, or the like) disposed in a patient's vasculature. Thepusher 3710 is further configured to receive the elongated guide member780, and the handle 3722 is configured to assist the clinician hold aportion of the guidewire or interventional devices extending proximallythrough the handle lumen 3724 thereby advancing the guidewire and/orinterventional devices through a catheter.

The length of the support tubular member 3711 can range from about 1″(2.54 cm) to about 60″ (152.4 cm) or larger. The support tubular member3711 comprises an inner wall defining the lumen 3724, the inner wall caninclude an annular, circular or any other suitable shape or dimensionsuitable for advancing guidewires and/or interventional devicestherebetween. The inner diameter of the support tubular member 3711 canrange from about 0.010″ (0.254 mm) to about 0.024″ (0.6096 mm). In someembodiments, the inner diameter of the of the support tubular member3711 is larger than 0.024″ (0.6096 mm), such that the pusher 3710 isconfigured to receive and translate larger guidewires and/or otherinterventional devices (e.g., 2-24 Fr). The outer diameter of thesupport tubular member 3711 is configured to be received into theproximal hub 3377 of a catheter or hemostasis valve through whichguidewires and/or other interventional devices will be advanced into thepatient's target site. The support tubular member 3711 can have athin-walled configuration, comprising a wall thickness that ranges fromabout 0.001″ (0.0254 mm) to about 0.005″ (0.127 mm), which allows thesupport tubular member 3711 to fit within the catheter hub whilemaintaining maximum clearance within the tubular member lumen 3724 forreceiving guidewires and/or interventional devices. By way ofnon-limiting example, an embodiment of the pusher 3710 configured fortranslating embodiments of anchor 700 and guide member 780 through an0.027″ micro catheter into a distal portion of the IPS can have asupport tubular member 3711 that is 6″ to 8″ (15.25 to 20.32 cm) long,with an outer diameter of 0.025″ (0.635 mm) and inner diameter of 0.020″(0.508 mm). Alternative embodiments can be configured for translatinglarger or smaller interventional devices through larger or smallercatheters; for example, embodiments of the pusher can be configured fortranslating neuro-interventional devices such as 0.010″, 0.014″, or0.018″ guidewires through 0.014″, 0.018″, or 0.021″ micro catheters.

The support tubular member 3711 of the elongated pusher 3710 can becomposed of metal (e.g., stainless steel, titanium, Nitinol) or plastic(e.g., polyamide, polyimide, PTFE, PEEK, polyester), or combinationsthereof. The support tubular member 3711 can have a multi-layeredconstruction, for example, stainless steel exterior with an HDPE innerlayer. In embodiments of the support tubular member 3711 composed bymetal, the tubular member 3711 can include progressive spiral cut orarticulated construction, where cut pattern or articulations areconfigured to create stiffness that transitions along the length of thesupport tubular member 3711 (e.g., stiffness transitions over its lengthand becomes stiffer nearer to the handle 3722. In such embodiments, thedistal portion 3714 of the support tubular member 3711 is more flexiblethan the proximal portion 3712 (e.g., stiffer near the handle 3722).Further, the inner wall of the support tubular member 3711 can include aPTFE liner or a lubricious coating such as PTFE, parylene, or othersuitable hydrophilic coatings, configured to reduce friction orfacilitate smooth translation of the guidewires and/or interventionaldevices through the tubular member lumen 3724.

Referring back to the handle 3722 coupled to the proximal portion 3712of the support tubular member 3711, the handle 3722 comprises an outersurface 3725, and a lumen 3726 in fluid communication with the lumen3724 of the support tubular member 3711 of the pusher 3710. The handlelumen 3726 is configured for receiving a proximal end 3712′ of theproximal portion 3712 of the support tubular member 3711. The handle3722 can be coupled to the proximal end 3712′ of the tubular member 3711by an adhesive (e.g., an ultraviolet light-cured adhesive,cyanoacrylate, or epoxy), using a press-fit connection, or any othersuitable techniques. In alternate embodiments, the proximal end 3712′ ofthe tubular member 3711 can be radially flared (e.g., outwardly flared,flared out, funnel-like configuration, or the like) with the handle 3722molded around the flared proximal end 3712′ of the tubular member 3711.The handle 3722 can be composed of polyethylene, HDPE, PTFE, PEEK, ABS,polycarbonate, ABS-polycarbonate, thermoplastic polyamide, orpolyoxymethylene, or the like. In alternative embodiments of the pusher3710, the handle can comprise PEEK, polyvinylidene difluoride, or otherthermoplastic polymers or materials suitable for autoclaving treatmentsthat can be used with a metal tubular member 3711.

The handle 3722 further comprises a lumen opening 3726′ configured forreceiving the guidewire and/or interventional devices for advancementinto a target site in a patient through the support tubular member lumen3724. In some embodiments, the handle 3722 can range in diameter (at itswidest portion) from about 0.75″ to 1.5 “(0.75 mm to 38.1 mm) or more,and have a length of about 0.5” to 1.5″ (12.7 mm to 38.1 mm) or more.The handle lumen 3726 defines an annular, circular or any other shapedspace suitable for advancing the guidewire and/or interventional devicestherebetween. The handle 3722 can comprise an ergonomic configuration,as shown in FIG. 13. The ergonomic configuration of the handle 3722 issuitable for providing a resting portion (i.e., surface 3725) for theclinician's fingers, typically sized for the clinician's thumb orfinger, while using the pusher 3710. The resting surface 3725 isconfigured to be contoured for resting a human thumb or finger, suchthat the clinician can use the surface 3725 to hold, pinch, press ormaintain a portion of the guidewire and/or the interventional devicesextending out from the handle 3722 while using the pusher 3710, with onehand only. By pinching the guidewire and/or interventional deviceagainst the resting surface 3725 of the handle 3722, the clinician canadvance the pusher 3710, the guidewire or the interventional devicesinto the catheter. Then, the clinician can release the pinch andwithdraw the pusher 3710 over the guidewire. The clinician may perform asequence of pinching the guidewire, advancing the pusher and pinchedguidewire, releasing the pinch and withdrawing the pusher over theguidewire (as shown in FIGS. 14C-E), which sequence can be repeateduntil the guidewire and/or the interventional devices translates throughthe catheter and reach their target site. The handle 3722 may includeother contour shapes or configurations (e.g., scallop, ramp, slopes orthe like) that allow the clinician to hold, pinch, press or maintain theguidewire and/or the interventional devices against the surface 3725 ofthe handle 3722. The surface 3725 can include a traction pad (e.g., athin strip of silicone, swallow ribs or the like) configured to increasethe friction coefficient between the handle and the clinician, to assistwith the holding of the guidewire and/or the interventional devicesagainst the handle 3722. The traction pad may comprise a single siliconepad disposed on the surface 3725 of the handle 3722 or a silicone tabthat folds over and sandwiches the guidewire and/or interventionaldevices pinched against the surface 3725 of the handle 3722.

The handle 3722 can further comprise features that facilitate use of thepusher 3710. In the embodiment of FIG. 13, the handle 3722 comprises aneck 3737 (e.g., annular indentation, or the like) configured to be heldor gripped by the clinician's fingers during use of the pusher 3710, asshown in FIGS. 14C-D. The handle 3722 further comprises a flange 3738(e.g., annular outward rim, protruding collar, or the like) distallydisposed from the neck 3737 of handle 3722. The neck 3737, either aloneor in combination with the flange 3738, is configured to assist theclinician's hold of the pusher 3710 and to control the push and pullmotions of the pusher 3710 relative to the guidewire, interventionaldevices and/or catheter, while maintaining the position of the pusher3710 at a desired location. Additionally, the handle 3722 can include ascalloped or tapered lead in to lumen opening 3726′ for additionalsupport for guidewire and/or interventional devices used with the pusher3710. In alternative embodiments, a portion of the handle 3722 caninclude a guidewire torque features (e.g., rotating collet to lock wireor device in place).

During advancement of the guidewire and/or interventional devices into atarget site of a patient using the elongated pusher 3710 of FIG. 13, theclinician introduces the guidewire and/or interventional devices throughthe lumen opening 3726′ of the handle 3722. Then, the clinician distallytranslates the guidewire and/or interventional devices into the pusher3710 (i.e., handle lumen 3726 and tubular member lumen 3724) whilemaintaining the proximal portion of the guidewire or interventionaldevices extending out of the handle 3722.

FIGS. 14A-F illustrate a method of use an elongated pusher accordingwith embodiments of the disclosed inventions. By way of non-limitingexample, FIGS. 14A-E illustrate the pusher 3710 of FIG. 13 to translatea guide member 780 through a catheter 3307 (e.g., micro catheter,introducer sheath or the like). In these embodiments, the catheter 3307has been advanced into the vasculature (e.g., the IPS) from a femoralvein access point in the patient. It should be appreciated that theelongated pusher 3710 constructed according to embodiments of thedisclosed inventions may be used in other interventional proceduresincluding, but not limited to, stent retriever delivery, distalprotection device delivery, foreign body retrieval, delivery loops andsnares, pacemaker implantation, and any other suitable medicalprocedure.

FIG. 14A depicts the guide member 780 being advanced into the distalopening 3714′ of the support tubular member 3711. It should beappreciated that anchor 700 coupled to the guide member 780 has alreadybeen inserted and translated through the catheter hub 3377 into theproximal portion of the catheter 3307 (not shown). Alternatively, thepusher 3710 and guide member 780 can be introduced simultaneously intothe catheter hub 3377. As shown, the clinician feeds the guide member780 through pusher 3710, via the distal opening 3714′ of the supporttubular member 3711, through tubular member lumen 3724 and handle lumen3726, such that the guide member 780 emerges from the opening 3726′ ofthe handle 3722. Alternatively, the clinician may feed the guide member780 through pusher 3710, via the opening 3726′ of the handle 3722,through the handle lumen 3726, into the tubular member lumen 3724. Then,the clinician advances the pusher 3710 over guide member 780 untildistal portion 3714 of support tubular member 3710 accesses the catheterhub 3377 of catheter 3307 (FIG. 14B).

In instances in which the body lumen is a blood vessel, the elongateguide member 780 is normally advanced into the blood vessel through anintroducer sheath 3307 having a proximal opening outside of the patientand a distal opening (not shown) within the blood vessel, in which caseadvancing the pusher tool 3710 may include advancing the distal portion3714 of the tubular body 3711 into the proximal opening of theintroducer sheath 3307. The proximal opening of the introducer sheath isnormally accessed via the proximal introducer hub 3377, in which casethe method may further include grasping to thereby stabilize theintroducer hub 3377 while advancing the distal portion 3714 of thetubular body 3711 through the hub 3377.

The clinician then holds, pinches, or presses the guide member 780against the handle 3722, as described above, and further advances thepusher 3710 and guide member 780 into catheter hub 3377 of catheter3307. (FIGS. 14C-14D). By pinching the guide member 780 against theresting surface 3725 of the handle 3722, the clinician can advance thepusher 3710 and guide member into the catheter 3307. Then, the cliniciancan release the pinch and withdraw the pusher 3710 over the guide member780, preferably while maintaining the distal portion 3714 of the supporttubular member 3711 within the catheter hub 3377. The clinician mayperform a sequence of pinching the guide member 780, advancing thepusher 3710, releasing the pinch and withdrawing the pusher 3710 overthe guide member 780 (as shown in FIGS. 14C-F), which sequence can berepeated until the guide member 780 translates through the catheter3307, with the support tubular member 3711 telescoping into the catheterhub 3377 and guide member 780 reaching the target site. The clinicianreleases the pinch of the guide member 780 against the handle 3722 andwithdraws the pusher 3710 over the guide member 780 after the guidemember reaches the target site.

FIGS. 15A-K illustrate another exemplary shunt 2200 constructed andimplanted according to embodiments of the disclosed inventions. Aproximal portion 2204 of the shunt 2200 includes an anchoring mechanism2227 (i.e., proximal anchor), and a valve 2209 (e.g., duck-bill, crosscut, elastic vales, molded silicone valves as disclosed herein, or othersuitable one-way valves). A distal portion 2202 of the shunt 2200includes an anchoring mechanism 2229. The shunt 2200 further comprisesan elongate body 2203 extending between the proximal 2204 and distal2202 portions. The anchoring mechanisms 2227 and 2229 include aplurality of respective deformable elements 2227 a and 2229 a (e.g.,arms) that are disposed radially outward in the deployed configurationof the shunt 2200 (FIG. 15A). Anchoring mechanisms 2227 and 2229 mayhave a preformed expanded or deployed configuration, for example, whenconstructed from super-elastic materials such as Nitinol®. The deployedanchoring mechanism 2227 engages the jugular bulb 108, the jugular vein106, the IPS wall 117, and/or another portion of the IPS 102, anchoringthe proximal portion 2204 of the shunt 2200 within the jugular vein 106,so that the valve 2209 is disposed within the jugular vein 106 or atleast facing the blood flowing through the jugular vein (e.g.,transversally disposed towards the vein), as shown, for example in FIGS.7E-F. Alternatively, the anchoring mechanism 2227 may engage the IPSwalls 114 and 117 at the junction 118 (not-shown). The deployedanchoring mechanism 2229 secures the distal portion 2202 of the shunt2200 within the CP angle cistern 138, so that CSF flows through theimplanted shunt 2200 into the jugular vein 106 (e.g., FIGS. 7E-F).

The anchoring mechanism 2227 and 2229 are formed by series of cuts 2222and 2222′ (e.g., kerfs, slots, key-ways, recesses, or the like) alongthe length of the respective proximal 2204 and distal 2202 portions ofthe shunt 2200 (FIGS. 15C1-G), forming the deformable elements 2227 a(FIGS. 15A-E) and 2229 a (FIGS. 15A, 15D-E, 15G, 15J). The cuts 2222 and2222′ and their patterns are preferably manufactured by laser cutting,etching or other suitable techniques. FIGS. 15D-F illustrate exemplarypatterns and dimensions of the cuts 2222 in the proximal portion 2204 ofthe shunt 2200, the cuts 2222 forming the deformable elements 2227 aconfigured to a flared open (e.g., funnel, flower-petal, or the like)deployed configuration (FIGS. 15A-B and 15I). The deformable elements2227 a in the flared-open deployed configuration of the anchoringmechanism 2227, as shown in detail in the perspective view of FIG. 15B,combined with a malecot distal anchor 2229 configuration, provides a“flarecot” shunt configuration as shown in FIG. 15A. Further, FIG. 15Iillustrates another perspective view of the flared anchoring mechanism2227. The deformable element 2227 a may comprise hinge-like points 2227b (e.g., living hinge, joint, or the like) to assist with the deploymentof the anchor 2227 into the flared configuration. Each of the deformableelements 2227 a is coupled to one or more adjacent deformable element2227 a defining a plurality of closed cells 2227 g, as shown in FIG.15I. The anchoring mechanism 2227 having the plurality of closed cells2227 g is configured to minimize disruption and allow passage of fluids(e.g., blood, CSF) through the anchor 2227 when anchoring the proximalportion 2204 of the shunt 2200 within the jugular vein 106.

Referring back to the anchoring mechanism or proximal anchor 2227 ofFIGS. 15A-B and 15I, the deformable elements 2227 a may include one ormore radiopaque markers 2227 c (e.g., gold, or other suitable radiopaquematerials) for imaging purposes during the delivery of the shunt 2200.The markers 2227 c assist with the deployment and/or placement of theanchoring mechanism 2227 at the target site within the patient. Further,suitable markers 2227 c can be included (e.g., embedded, attached,coupled) or applied (e.g., coatings) in/on the deformable elements 2227a. The radiopaque marking scheme on the proximal anchoring mechanism2227 depicted in FIGS. 15A-B and 15I allows the clinician to visualizedeployment of the proximal anchoring mechanism about the jugular vein106, as the anchor transitions from a radially compressed to a flared,deployed configuration. In the embodiments of FIGS. 15A-B and 15I, eachof deformable elements 2227 a include a first end portion 2227 a′ and asecond end portion 2227 a″, wherein at least two deformable elements2227 a are coupled at their respective first end portions 2227 a′ havingan interlocking element 2227 d therein. The anchoring mechanism 2227includes one or more interlocking elements 2227 d having a respectivemarker 2227 c. The interlocking elements 2227 d of the anchoringmechanism 2227 are sized and dimensioned to detachably engage the shunt2200 to the delivery system (e.g., pusher member or the like), describedin FIG. 15C-1 in further detail. Each interlocking element 2227 dincludes a substantially round shape, as shown in FIGS. 15A-B, 15I, and15K, configured to arcuate in the delivery configuration to conform tothe delivery system, as shown in FIGS. 15C-1, 15C-2 and 15L. Theinterlocking elements 2227 d may include any other suitable shape, suchas spherical, rectangular, or the like. Further, each interlockingelement 2227 d have a recess 2227 e (e.g., hole, eyelet, cavity, or thelike) configured for receiving a respective marker 2227 c. As shown inFIGS. 15A-B and 15I, the markers 2227 c are formed as rivets by pressinga respective marker 2227 c into the corresponding recess 2227 e. Themarkers 2227 c may extend or protrude out of the interlocking elements2227 d (e.g., riveted), as shown in FIGS. 15A-B and 15I, or may beflushed with the interlocking elements 2227 d (e.g., welded), or may becoupled to the interlocking elements 2227 d with any other suitabletechniques or combinations thereof.

The interlocking elements 2227 d of the proximal anchor 2227 are shapedand dimensioned to detachably engage (i.e., engage and disengage) aninterlocking element 3336 coupled to the distal portion 3314 of a pushermember 3310, as shown in FIGS. 15C-1 and 15C-2. The pusher member 3310(e.g., hypotube, such as a stainless steel hypotube (FIGS. 15C-1 and15C-2) comprises a plurality cuts 3311 to increase flexibility, aradiopaque marker 3314 (FIGS. 15C-1 and 15C-2) for imaging purposes, anda distal interlocking element 3336 (FIGS. 15C-1 and 15C-2) configured tointerlock with corresponding interlocking elements 2227 d of theanchoring mechanism 2227. FIGS. 15C-1 and 15C-2 illustrate the interfacebetween the pusher member 3310 and anchoring mechanism 2227 of the shunt2200, having the interlocking elements 2227 d of the proximal anchor2227 engaged with the interlocking element 3336 of the pusher member3310. FIG. 15C-1 further depicts the valve 2209 disposed on the proximalportion 2204 of the shunt 2200 within the compressed anchoring mechanism2227. The pusher member 3310 is configured to deliver the shunt 2200through a delivery catheter while avoiding contact, bumping orinterfering with the valve 2209. While the interlocked anchoringmechanism remains compressed within lumen 3305 of the delivery catheter3304, the clinician can advance and retract the shunt 2200 within thedelivery catheter prior to shunt deployment via pusher member 3310(e.g., advancing shunt slightly proximal of the penetrating element 3350to provide additional column strength to the delivery catheter 3304during the penetration step of the shunt implant procedure, oralternatingly advancing the delivery catheter 3304 and then shunt 2200through lumen 3305 to maintain the flexibility of the delivery assemblywhile accessing and navigating through tortuous anatomy).

In the embodiment of FIGS. 15A-J, the proximal anchor 2227 is composedof super-elastic materials (e.g., Nitinol®) having a preformed, flaredconfiguration. When the proximal portion 2204 of the shunt 2200 isadvanced out of the delivery catheter by translating the pusher member3310 and/or withdrawing the delivery catheter, with or without holdingpusher member 3310 member in place, the anchor interlocking elements2227 d disengage from the interlocking element 3336 of the pusher member3310 by the anchor 2227 assuming the flared configuration, shown inFIGS. 15A-B and 15I. In some embodiments, the flared configuration ofthe proximal anchor 2227 and/or disengaging of the anchor interlockingelements 2227 d from the interlocking element 3336 of the pusher member3310 may be actuated and controlled by the clinician.

Referring back to the anchoring mechanism or distal anchor 2229 of theshunt 2200, FIG. 15G illustrates exemplary patterns and dimensions ofthe cuts 2222′ in the distal portion 2202 of the shunt 2200 (FIGS. 15A,15D-E, and 15G). The cuts 2222′ are parallel and radially spaced to formthe deformable elements 2227 a configured to extend radially outwardwhen deployed assuming a malecot configuration (FIGS. 15A and 15J). Eachof the deformable elements 2229 a has a respective hinge-like point 2229b (e.g., living hinge, joint, or the like) configured to move radiallyoutward from the axis of the shunt 2200 in a hinge-like fashion,allowing the deformable elements 2229 a to be outwardly disposed whendeployed. The cuts 2222′ forming the deformable elements 2227 a of thedistal anchor 2229 are substantially longitudinal along the axis of theshunt 2200 allowing the distal anchor 2229 and/or distal portion 2202 ofthe shunt 2200 to maintain a suitable column strength and pushabilitythrough tissue during deployment at a target site.

FIG. 15H illustrates exemplary patterns and dimensions of the cuts 2210along the elongated body 2203 of the shunt 2200. The cuts 2210 of theelongated body 2203 may have a variety of suitable patterns. The cuts2210 and their patterns are preferably manufactured by laser cutting theelongated body 2203 of the shunt 2200. Alternatively, the cuts 2210 andtheir patterns may be manufactured by etching or other suitabletechniques. For example, with a laser oriented orthogonal to thelongitudinal axis of the body 2203 and with a laser capable of holdingbody 2203 while rotating and advancing the body relative to the fixture,the laser can be activated and deactivated to form specific cut patternsin shunt body 2203. The laser cutting of the elongated body 2203 creates1.5 cuts 2210 per rotation of the body, having a cut balance of about210° of rotation with laser on, and then 30° of rotation with laser off.Further, while the pitch of the cut pattern is approximately 0.0070″(0.1778 mm) in the embodiments of FIG. 15H, each cut 2210 may have avariety of widths; for example 0.005″ (0.12446 mm). Additionally, thepitch of the cut pattern may be varied. For example, the pitch of thecut pattern of the body 2203 proximately disposed to the proximalportion 2204 and/or to the distal portion 2202 of the shunt 2200 may belarger/wider than the pitch of the cut pattern along the middle sectionof the body 2203, as shown in FIGS. 15D-E . . . .

It should be appreciated that the above disclosed units are exemplarydimensions, angles and properties of the shunt 2200, which are notintended to limit the embodiment of FIGS. 15A-K.

As previously disclosed, embodiments of the disclosed shunts can includean anti-thrombotic coating on all or a portion of the exterior of thedevice, to minimize clotting in the IPS after shunt deployment. Suchanti-thrombotic coatings may comprise phosphorylcholine (e.g., Lipidure®products available from NOF Corporation) or Heparin-based compositions(e.g., CBAS® Heparin Surface available from Carmdea AB). Anti-thromboticcoatings can also be applied to anchor 700 and/or elongate guide member780 to further minimize the risk of clotting in the IPS during the shuntimplant procedure.

FIG. 16 illustrates a delivery catheter 3300, constructed according toembodiments of the invention. The delivery catheter 3300 (or distal mostportion of the delivery catheter) can include an oversheath member 3300″(e.g., a larger, concentric sheath that covers the outer diameter of thedelivery catheter and/or the penetrating element). The oversheath 3300″can translate longitudinally about the delivery catheter, and can beretracted proximally to expose the needle tip 3350″ for the penetrationstep of the procedure. The oversheath 3300″ of FIG. 16 is disposed overa delivery catheter 3304 and penetrating element advanced over a guidemember 3308″; the bands 3303″ located proximal of the penetratingelement comprise radiopaque markings to confirm orientation of thepenetrating element and assess penetration trajectory during a shuntdeployment procedure. The oversheath member covers the penetratingelement as the delivery system navigates through the patient'svasculature, thereby preventing inadvertent vessel punctures. Theoperator can position the distal portion of the oversheath adjacent orabutting the target site penetration along IPS wall 114 until theoperator is ready to expose the penetrating element or advance thepenetrating element through the tissue into the CP angle cistern 138.

As described above, FIGS. 17A-B illustrate an exemplary elongate guidemember 780 for delivering of the anchor 700 at a target site,constructed according to the disclosed inventions. FIGS. 18A-Eillustrate another exemplary elongate guide member 780 for delivering ofthe anchor at a target site, constructed according to the disclosedinventions. The elongate guide member 780 of FIGS. 18A-E includes aflat, rectangular cross-sectional profile, as described in FIG. 3D andFIG. 11. As shown in FIGS. 18A-E, the elongate guide member 780 iscoupled to the proximal portion 740 of anchor 700 via joint 744, aspreviously described (e.g., directly or indirectly, fixedly ordetachably coupled or the like). FIGS. 18A-E illustrate exemplarydimensions and properties of the interface of the elongate guide member780 with the anchor 700, which are not intended to limit the embodimentof the interface disclosed herein. In the embodiments of FIGS. 18D-E,the joint 744 between the anchor 700 and the elongate guide member 780includes a rotatable element 745 configured to allow the elongate guidemember 780 to rotate clockwise and/or counter-clockwise with respect tothe anchor 700. The independent rotation of the elongate guide member780 relative to the anchor 700 via the rotatable element 745 at thejoint 744 allows for the elongate guide member 780 to assume a desirableorientation through the curved portion of the IPS 102 during deliveryand/or after deployment of the anchor 700. For example, the anchor 700may be delivered at a random orientation at the IPS 102, yet theelongate guide member 780 would assume a desirable orientation byrotating (if needed).

FIGS. 19A-I depict an embodiment of a delivery assembly 300 comprisingdelivery catheter 3304 and penetrating element guard or guard member4000. The guard member 4000 covers the penetrating element 3350 duringnavigation of the delivery catheter 3304 (FIG. 19A) through thepatient's vasculature to the target penetration site on IPS wall 114 andduring withdrawal of delivery catheter 3304 after shunt deployment,thereby preventing inadvertent puncture or damage to other components ofdelivery assembly (e.g., guide catheter) and the patient's vasculature.As will be further described below, the clinician can actuate a pullwire 4010 to retract guard 4000 proximally and expose the penetratingelement 3350 to the dura of IPS wall 114 prior to the penetration stepof the shunt implant procedure and, optionally, then re-cover thepenetrating element 3350 after the penetration step (e.g., after distalanchoring mechanism 229 of the shunt has been deployed). Radiopaquemarkers located on the guard 4000 and delivery catheter 3304 provide anindication of whether the guard has been retracted and penetratingelement 3350 is exposed or the guard remains in a deliveryconfiguration, covering the penetrating element 3350 for navigationthrough the patient's vasculature, as will be further described below.

With reference to FIG. 19A, the distal portion 3344 of delivery catheter3304 comprises penetrating element 3350 and a radiopaque marker 3354. Aspreviously described, delivery catheter 3304 includes a first lumen 3315to accommodate elongate guide member 780 and a second lumen 3305 toaccommodate a shunt 2200 (not shown). The guard member 4000 comprises apull wire 4010, the pull wire 4010 having a distal portion 4011 attachedto a guard body 4000, where the pull wire 4010 is configured totranslate the guard body 4000 proximally or distally relative to theshunt delivery catheter 3304 so as to at least partially expose orcover, respectively, the penetrating element 3350. The distal portion4011 of pull wire 4010 is embedded or encased within guard 4000 (as willbe further described below) and includes an attachment point 4011 a(e.g., a weld) to radiopaque marker 4015 also embedded within guard 4000(as will be further described below). The guard 4000 further comprises afirst lumen 4020 configured to receive the penetrating element 3350 andallows the guard 4000 to retract proximally (direction of left-handarrow d2 in FIG. 19A) over the penetrating element 3350 and distalportion of 3344 of delivery catheter and distally (e.g., to re-coverpenetrating element 3350, direction of right-hand arrow d2 in FIG. 19A)via pull wire 4010. The enlarged circumference in the distal portion3344 of delivery catheter 3304 at interface point 3315 a where theelongate guide member 780 enters the first lumen 3315 of the deliverycatheter prevents guard 4000 from retracting further proximally over thedelivery catheter. Guard 4000 can advance distally, via pull wire 4010and as will be further described below, to re-cover penetrating element3350. As shown in FIG. 19A, the shunt delivery catheter 3304 includes athird lumen 3325 that extends throughout the length of the deliverycatheter, from the distal portion 3344 to the proximal portion 3342;third lumen 3325 accommodates pull wire 4010 of guard 4000.

FIGS. 19B and 19C show cross section and perspective views,respectively, of penetrating element guard or guard member 4000. FIG.19B depicts a guard member 4000 in a delivery configuration with respectto the distal portion 3344 of delivery catheter 3304 (represented bydashed lines in the figure), covering penetrating element 3350.Penetrating element 3350 is positioned within lumen 4020 of the guard400 and inside of radiopaque marker 4015 embedded or encapsulated withinthe walls of guard 4000 (as will be further described below). The guardmember 4000 can be approximately 0.5″ (1.27 cm) long or other suitabledimensions sufficient to cover penetrating element 3350 on the distalportion 3344 of the delivery catheter. The guard lumen 4020 is sized toallow guard 4000 to retract proximally over the penetrating element 3350and distal portion 3344 of the delivery catheter, indicated by thedirection of the left-hand arrow d2 shown in FIG. 19A. For example, theinner diameter of guard lumen 4020 can be approximately 0.0385″ (0.09779cm).

Marker 4015 comprises a cylindrical profile (as can be seen in FIGS.19B-D and 19G) such that penetrating element 3350 can reside inside ofmarker 4015 and the guard first lumen 4020 as depicted in FIG. 19A; thealloy material of marker 4015 shields the concentrically disposedpenetrating element 3350 and can prevent the penetrating element frominadvertently puncturing through the guard 4000 when the distal portionof 3344 of delivery catheter 3304 bends as the clinician navigates thedelivery assembly 300 through tortuous anatomy to the target penetrationsite along IPS wall 114. The distal portion 4004 of the guard 4000 has abeveled/tapered edge, as shown in FIGS. 19B and 19C. The bevel/taperfacilitates access to narrow or tortuous vasculature as the cliniciannavigates the delivery assembly distally beyond the inferior vena cava(e.g., to access and navigate through junction 118 of jugular vein 106and IPS 102). The guard 4000 may comprise a second lumen 4035 toaccommodate elongate guide member 780 as shown in FIG. 19C. The deliveryassembly 300 comprising delivery catheter 3304 and guard 4000 canadvance along the elongate guide member 780 distally, toward the targetpenetration site; that is, the guide member 780 passes through secondlumen 4035 of the guard 4000 and lumen 3315 of delivery catheter 3304 toassist delivery catheter navigation through the patient's vasculature.

FIG. 19D depicts the pull wire 4010 and radiopaque marker 4015subassembly of guard 4000. Pull wire 4010 can comprise PFTE-coatedstainless steel or other suitable materials. The diameter of pull wire4010 can range from about 0.003″ to 0.012″ (0.0762 mm to 0.3048 mm).While pull wire 4010 depicted in FIG. 19B-D has a circularcross-sectional profile, other pull wire embodiments can includenon-circular cross-sectional profiles (e.g., rectangular, crescent). ThePTFE coating on pull wire 4010 increases the lubricity of the wirewithin the third lumen 3325 of delivery catheter 3304, therebyfacilitating smooth proximal and distal actuation of guard 4000 toexpose and re-cover penetrating element 3350 (not shown in FIG. 19D).Radiopaque marker 4015 can comprise platinum-iridium 90/10 alloy orother suitable materials that provide sufficient radiopacity and allowfor a connection point 4011 a between the marker and distal portion 4011of pull wire 4010. The inner diameter of marker 4015 can be 0.0385′ orother suitable dimensions compatible with a guard lumen 4020 sufficientto accommodate the distal portion of delivery catheter 3344 andpenetrating element 3350. As shown in FIG. 19D, the distal portion 4011of pull wire 4010 does not include the PTFE coating depicted on the bodyportion of pull wire 4010; the uncoated stainless steel distal portion4011 of pull wire allows for a weld or other connection point 4011 a toradiopaque marker.

FIGS. 19E and 19F show cross section views of the proximal portion 4002and distal portion 4004, respectively, of the guard member 4000. Asdepicted in FIG. 19E, marker 4015 and pull wire 4010 are embedded orencapsulated within the wall of guard 4000. Guard 4000 can comprisepolymeric materials such as polyether block amide (Pebax® available fromArkema Group), HTPE, PTFE, urethanes or the like. Pebax embodiments ofguard 4000 can range from 27D to 70D hardness (e.g., Pebax 63D). Thewall thickness of guard 4000 can vary depending on top-to-bottomorientation of the guard. The top portion of guard 4000 (represented byline A in FIG. 19E) can range from about 0.002″ to 0.006″ (0.0508 mm to0.1524 mm) or larger. The bottom portion of guard 4000 (represented byline B in FIG. 19E) can range from about 0.008″ to 0.014″ (0.2032 mm to0.3556 mm) or larger.

As previously disclosed and during the shunt implant procedure, anclinician can deploy an anchor 700 distal to a target penetration sitealong IPS wall 114. Thereafter, the clinician advances a deliveryassembly 300 comprising delivery catheter 3304 and penetrating elementguard 4000 via elongate member 780 to the target penetration site. Theradiopaque marking 3354 on the distal portion 3344 of the deliverycatheter 3304 and radiopaque marking 4015 within guard 4000 providereference points for the clinician to visualize the location of thedelivery assembly and penetrating element 3350 at the target penetrationsite. When the clinician is prepared to penetrate IPS wall 114, theclinician can pull the proximal end of pull wire 4010 proximally, whichretracts guard 4000 proximally over the distal portion 3344 of deliverycatheter (indicated by the direction of the left-hand arrow d2 shown inFIG. 19A) and exposes penetrating element 3350 from the deliveryassembly 300. Observing the transition of marker 4015 in guard 4000proximally towards and/or until it abuts marker 3354 on the distalportion 3344 of the delivery catheter (e.g., in the direction of arrowd2 shown in FIG. 19A) confirms that guard 4000 actuated properly andpenetrating element 3350 is exposed from the delivery assembly in thepatient's vasculature. Conversely, after shunt implantation, theclinician can advance pull wire 4010 distally to re-cover penetratingelement 3350 and confirm that the guard 4000 is in a delivery orwithdrawal configuration (e.g., penetrating element not exposed in IPS102 or jugular vein 106 lumens).

FIG. 20 depicts an alternate embodiment of penetrating element guard4000. For ease in illustration, like features of the penetrating elementguard 4000 and delivery catheter 3304 shown in FIG. 20 have been giventhe same reference numerals from FIGS. 19A-F. Guard 4000 comprises aguard 4000 having a full-length, “oversheath” configuration; that is,guard 4000 is a sheath that extends along the length of and over thedelivery catheter 3304 disposed concentrically within guard lumen 4020.Guard 4000 can be retracted proximally (direction of left-hand arrow D2in FIG. 20), e.g., by a clinician pulling on the proximal portion ofguard 4000 to uncover and expose a protected penetrating element 3350.Optionally, guard 4000 can include a scored or weakened portion (e.g.,indicated by dotted line d1 in FIG. 20) that splits or tears (e.g.,along the longitudinal axis of the guard) to facilitate guardretraction.

Guard 4000 includes a second lumen 4035 that accommodates elongate guidemember 780. Lumen 4035 can extend from the distal portion or end ofguard 4000 and include an exit port 4035 a located in the distal portionof guard 4000, as shown in FIG. 20. As compared to the guardconfiguration described in connection with FIGS. 19A-F, the guardconfiguration shown in FIG. 20 simplifies the design of the deliveryassembly 300 by eliminating pull wire 4010 and a corresponding pull wirelumen 3325 in the delivery catheter 3304.

FIGS. 21A-M depict an alternate embodiment of delivery catheter 3304.FIGS. 21C and D show longitudinal side and cross section views,respectively, of delivery catheter 3304. FIGS. 21A and B show crosssection views of delivery catheter 3304 at reference lines in FIG. 21C,respectively, looking from the distal portion 3344 of the cathetertowards the proximal portion. FIG. 21I shows another longitudinal sideview of the delivery catheter of FIGS. 21A-M. FIGS. 21F-M depict crosssection views of delivery catheter 3304 at various points along thelongitudinal axis corresponding to the reference line designations inFIG. 21I.

With respect to FIGS. 21C, D, and I, the depicted delivery catheter 3304includes a beveled-needle penetrating element 3350 on the distal portion3344 of the delivery catheter. The penetrating element 3350 can be fixedto the delivery catheter and, as depicted, is welded to reinforcingmember 1345 (further described below). Delivery catheter includes threedistinct radiopaque marker bands: a distal most marker 3354 locatedabout the proximal portion of penetrating element 3350, an intermediatemarker 3354 a, and proximal most marker 3345 b. A first lumen 3315 inthe delivery catheter accommodates elongate guide member 780 and lumen3315 can include a polymeric liner 3306 material such as PTFE (FIG. 21B)to increase the lubricity of the lumen and facilitate smooth motion ofthe delivery catheter 3304 over guide member 780.

As depicted, first lumen 3315 has a rapid-exchange configuration anddoes not span the entire longitudinal axis of deliver catheter 3304,although such a configuration is possible in other embodiments. Markerbands 3354 a and 3354 b reinforce the distal 3315 a and proximal 3315 bopenings of lumen 3315, as shown in FIGS. 21A and 21K-L. FIG. 21Dincludes longitudinal dimensions along the length of delivery catheter3304, measured from the proximal portion of penetrating element 3350 tothe distal opening 3315 a of first lumen 3315 (0.16″/0.4064 cm), to thedistal edge of marker band 3354 a (0.17″/0.4318 cm), to the distal edgeof marker band 3354 b (7.95″/20.193 cm), to the proximal opening 3315 bof first lumen 3315 (8″/20.32 cm), and to the proximal portion ofdelivery catheter 3304 (39.37″/100 cm). Further, delivery catheter 3304includes a second lumen 3305 to accommodate a shunt and shunt pusherdelivery assembly as disclosed herein. Second lumen 3305 includes apolymeric liner material 3306 as indicated in FIGS. 21E, 21E-1, 21E-2 toFIG. 21M, such as PTFE.

The outer diameter of delivery catheter 3304 of FIGS. 21A-M varies alongthe longitudinal axis. The cross section views of FIGS. 21F-M, workingfrom the distal most cross-section to the proximal most cross-sectionalong the axis of delivery catheter 3304, correspond to the referencelines shown in FIG. 21I as follows: FIG. 21J at reference line E-E inFIG. 21I; FIG. 21F at reference line F-F in FIG. 21I; FIG. 21K atreference line G-G in FIG. 21I; FIG. 21G at reference line H-H in FIG.21I; FIG. 21L at reference line I-I in FIG. 21I; FIG. 21H at referenceline J-J in FIG. 21I; and FIG. 21M at reference line K-K in FIG. 21I.Each of FIGS. 21A-B and F-M specify the maximum outer diameter along thelongitudinal axis of the delivery catheter 3304 at the location of theparticular cross section depicted, which varies depending on thelongitudinal location of the cross section along the axis of thecatheter (e.g., ranging from 0.036″ to 0.046″/0.09144 cm to 0.11684 cm).FIGS. 21K, 21F, and 21J depict a gradually tapering outer diameter inthe distal portion of the delivery catheter 3304, moving in the distaldirection along the axis of the catheter (i.e., from 0.046″ to0.036″/0.11684 to 0.09144 cm), which facilitates access to tortuousanatomy and narrowings in the vasculature (e.g., junction 118 of jugularvein 106 and IPS 102).

While FIGS. 21A-M and the foregoing description reference a two-lumendelivery catheter 3304, additional embodiments of the delivery cathetercan include a third lumen (e.g., lumen 3325 of 19A, FIGS. 29A-D toaccommodate, for example, a pull wire of a penetrating element guard4000, as further described below) and fourth lumen (e.g., lumen of toaccommodate, for example, a second pull wire of a penetrating elementguard 4000, as further described below and shown in FIGS. 64D-E).

Criteria for selecting a particular needle as the penetrating element3350 of a delivery assembly 300 include bevel length, force required topenetrate IPS wall 114, and needle wall thickness. Bevel length isinversely related to the puncture force required to penetrate IPS wall,though longer bevels can make navigation of delivery assembly 300 moredifficult as compared to shorter bevels, particularly in tortuousanatomy, given that needles do not flex as the distal portion 3344 ofthe delivery catheter 3304 navigates through the vasculature. Lowerpuncture forces facilitate a smooth penetration step of the shuntimplant procedure, as the penetrating element passes through IPS wall114 into the subarachnoid space. Puncture force for candidatepenetrating element embodiments can be assessed in vitro using a durasurrogate, e.g., DuraGuard® Dural Repair Patch available from SynovisSurgical Innovations, and force gauge as further described in U.S.patent application Ser. No. 14/929,066 filed on Oct. 30, 2015.Penetrating element embodiments comprising a needle configuration canhave a puncture force of about 0.1 pounds-force or less. A thinnerneedle wall minimizes the gap between the anastomosis through IPS wall114 and the outer surface of deployed shunt 2200. Reducing this gap isclinically significant to minimize or eliminate venous blood fromleaking from the IPS 102 or CS 104 through the anastomosis (e.g.,between the penetration tract through IPS wall 114 and the outer surfaceof implanted shunt 2200) into the subarachnoid space and, conversely,CSF leaking from the subarachnoid space into the IPS lumen.

FIGS. 22A-F illustrate yet another exemplary shunt 2200′ constructed andimplanted according to embodiments of the disclosed inventions. For easein illustration and disclosure, the features, functions, andconfigurations of the shunt 2200′ that are the same as in the shunt ofthe present disclosure (e.g., FIGS. 15A-J) and in the relatedapplication, are incorporated by reference herewith; the differenceswill be described in further detail below. The shunt includes anelongate body 2203 extending between the proximal 2204′ and distal 2202portions and having a lumen. The body 2203 of the shunt includesselective cuts 2210 (e.g., kerfs, slots, key-ways, recesses, or thelike) forming transition areas configured to vary the flexibility of theshunt 2200′, such as, from the proximal portion 2203 a (less flexible)to the distal portion 2203 c (more flexible), as shown in FIGS. 22A and22D-E. As better appreciated in the embodiment of FIG. 22E, the proximalportion of the shunt further includes an anchoring mechanism 2227′(i.e., proximal anchor), similar to the distal anchoring mechanism 2229of the shunt 2200′ and previously described distal anchoring mechanism2229. The anchoring mechanisms 2227′ and 2229 include a plurality ofrespective deformable elements 2227 a′ and 2229 a (e.g., arms) that aredisposed radially outward in the deployed configuration of the shunt. Asshown in FIGS. 22A-B and 22D-E, the proximal anchoring mechanism 2227′further includes a proximal interlocking element 2227 d′ (e.g., eyelet,slot, groove, or the like) configured to interlock with correspondinginterlocking elements 3336′/3336 b of a pusher member. The proximalinterlocking element is better appreciated in FIGS. 22B, and 22F. Theanchoring mechanisms 2227′ and 2229 include radiopaque markers 2227 c′and 2229 c (e.g. annular, ring, angled-arrow marker or the like), whichare shown as press flush in FIGS. 22A-B.

FIGS. 22A-G discloses exemplary dimensions, cut patterns, angles,configurations and/or properties of the shunt 2200′, pusher member3310′, radiopaque markers 2227 c′, and the interlocking elements 2227 d′and 3336′. It should be appreciated that the disclosed dimensions, cutpatterns, angles, configurations and/or properties are exemplary and notintended to limit these embodiments.

FIGS. 23A-B and 24A-F illustrate exemplary interfaces of the deliverycatheter 304, pusher member 3310′ and shunt 2200′, according toembodiments of the disclosed inventions (e.g., FIG. 6). The deliverycatheter 304 may further comprise a hypotube providing suitable columnstrength and flexibility, as previously described in 12A-C. FIGS. 23A-B,the pusher member 3310′ and shunt are disposed within the deliverycatheter lumen 305 and having their respective interlocking members3336′/3336 b and 2227 d′ engaged, as shown in FIGS. 23A-B and FIGS.24A-B.

FIGS. 23A-B illustrate the pusher member and shunt interface constrainedwithin a delivery catheter 304 and/or the pusher member and shuntinterface as if advanced out of the distal end opening of the deliverycatheter and before the respective interlocking elements separate torelease the shunt 2200′ from the pusher member 3310′. Although, therespective interlocking members of the pusher member 3310′ and the shunt2200′ are engaged in FIGS. 24A-B, it should be appreciated that pushermember 3310′ and shunt 2200′ interface will disengage (e.g., pusherinterlocking member 3336′/3336 a-b outwardly expands or flares out) whenthe interface is no longer disposed within the delivery catheter lumen305, as shown in FIGS. 24C-D.

FIGS. 24E-F illustrate the pusher member 3310′ and shunt 2200′ interfacewhere the interlocking members 3336′/3336 a-b of the pusher member 3310′outwardly expanded (e.g., flared out) and the shunt 2200′ is disengagedfrom the pusher member 3310′. Further, the proximal anchoring mechanism2227′ of the shunt 2200′ transitions from the delivery configuration(FIGS. 22A-B and FIGS. 24A-B) to the deployed expanded configuration(FIGS. 24C-F).

FIGS. 25A-0 illustrate embodiments of the valve 2209″ constructedaccording to embodiments of the disclosed inventions. The shunt 2200includes at least one valve 2209″, as shown, for example, in FIGS.15A-B. The valve 2209″ regulates the rate of CSF flow through the shunt2200, while allowing flow of CSF only in one direction, i.e., from thedistal portion 2202 located in the subarachnoid space to the proximalportion 2204 of the shunt 2200 located in the venous anatomy. The valve2209 may be disposed at any suitable location within the body 2203 ofthe shunt 2200, for example, proximate to or at the proximal portion2204, as shown in FIG. 15A, to the distal portion 2202, and/or inbetween said portions 2202, 2204 (not shown). In certain embodiments,multiple valves can be disposed at different locations within the shunt2200.

The valve 2209″ can include a specific cracking pressure that, when metor exceeded by the positive pressure gradient between the subarachnoidspace and venous system, opens the valve thereby facilitating CSF flowfrom the CP angle cistern into the jugular vein. For example, thecracking pressure of valve 2209 can be configured from about 3 mm Hg toabout 5 mm Hg and/or when the differential pressure between thesubarachnoid space and venous system reaches from about 3 mm Hg to about5 mm Hg; however, other cracking pressures can be configured in valve2209″ depending on the particular clinical needs of the patient and aslow as about 0.5 mm Hg. Further, a desired rate of flow is in a rangebetween 5 ml per hour to 20 ml per hour and more desirable between 10 mlper hour to 18 ml per hour under normal differential pressure conditionsbetween the subarachnoid space and venous system. In some embodiments,the desired flow rate of CSF is approximately 10 ml per hour. In a24-hour period, the flow of CSF through shunt 200 can be between 200 mlto 300 ml (e.g., 200, 225, 250, 275, or 300 cm³).

The valve 2209 may have a variety of suitable features, and comprises amolded silicone element configured to be coupled to the shunt 2200 influid communication with the shunt lumen 2207 and/or liner 2212. Forexample, the valve 2209′ of FIG. 25E is a one-way valve 2209′ having acylindrical body 2219 comprising a lumen 2237 and an end portion dome2239. The dome 2239′ comprises two or more leaflets 2290′ on the outerportion of the dome (FIG. 25E) formed from cutting or slitting the part,and two or more leaflets 2290 on the inner portion of the dome 2239′(FIG. 30H) formed through the silicone molding process. The leaflets2290 and 2290′ are configured to open the valve 2209′ facilitating CSFflow through the lumen 2237 into the jugular vein 106. The outerleaflets 2290′ may be formed by creating cuts or slits in the moldedsilicone element of the valve 2209′. As shown in FIGS. 25E and 25H, thevalve 2209′ includes three inner leaflets 2290, similar to a heartvalve, molded into the valve. In addition, as shown in FIGS. 25E and25H, the inner surface of the dome 2239 of valve 2209′ can includevarious tiling patterns to increase the available surface area thatfluid flowing through the valve contacts to crack or open the valve fromits resting or closed state. Other tiling patterns on the interiorportion of the valve dome are possible to accommodate specific valvecracking pressures.

FIG. 25A illustrates an alternate embodiment of valve 2209″ comprising asimple dome 2239″. Two or more leaflets (not shown) can be created inthe dome 2239″ in FIG. 25A (e.g., by cutting or slitting with a trocaror blade, using an excimer laser, etc.) to achieve the desired crackingpressure of the valve (e.g., varying the extent of slitting across thesurface of the valve dome and/or along the wall of valve 2209″). FIGS.25B-D illustrate exemplary dimensions (in inches) of the valve 2209″;exemplary dimensions of the dome thickness for molded silicone valvescan also range from about 0.001″ to 0.004″ (0.0254 mm to 0.1016 mm). Asshown in FIG. 25B, the cylindrical body 2219 of embodiments of the valve2209″ comprises at least two portions 2219 a and 2219 b with variablewall thickness, the portion 2219 a comprises a larger wall thickness ofapproximately 0.006″ (0.1524 mm) that the portion 2219 b having a wallthickness of approximately 0.003″ (0.0762 mm), as shown in FIGS. 25B and25G for valve 2209′. The thicker portion of the valve wall thickness canbe used for handing the part during manufacturing or assembly steps, orcan be an intended feature of the design (e.g., to allow incorporationinto the shunt frame). The length of the portions 2219 a of the valve2209′/2209″ is approximately 0.030″ (0.762 mm), while the length of theportions 2219 b including the dome 2239′/2239″ is approximately to0.040″ (1.016 mm), as shown in FIGS. 25B and 25F. The dome 2239′comprises a wall thickness with variable ranges shown in FIGS. 25G and25I.

FIGS. 25J-O illustrate alternative embodiments of valve 2209 includingexemplary dimensions (in inches) having outer leaflets 2290′. As shownin FIGS. 25J-L, the valve 2209′″ includes three inner leaflets 2290(FIG. 25M) and three outer leaflets 2290′ (FIG. 25N). FIG. 25Jillustrates a perspective view of an embodiment of the valve 2209′″including the three sets of inner and outer leaflets 2290 and 2290′,respectively. In addition, the exterior portion of the valve dome 2239″includes three ribs 2293 as shown in FIGS. 25J and 25N; the outer ribs2293 can increase the outer surface area of the valve 2209′″ to providemore robust backflow prevention of fluid through the valve (e.g.,preventing backflow of venous blood through the valve into thesubarachnoid space). FIGS. 25K-O illustrate exemplary dimensions (ininches) of embodiments of the valve 2209′″ depicted in FIG. 25J.Similarly to FIG. 25C, the cylindrical body 2219 of the valve 2209′″ ofFIG. 25L comprises at least two portions 2219 a and 2219 b with variablewall thickness, the portion 2219 a comprises a larger wall thicknessthat the wall thickness of the portion 2219 b. For example, the wallthickness of portion 2219 a can range from approximately 0.006″ (0.1524mm) to 0.001″ (0.0254 mm), and the wall thickness of portion 2219 b canrange from approximately 0.003″ (0.0762 mm) to 0.0003″ (0.00762 mm). Thelength of the portions 2219 a of the valve 2209 can range fromapproximately 0.030″ (0.762 mm) to 0.005″ (0.127 mm), while the lengthof the portions 2219 b including the dome 2239 can range fromapproximately to 0.040″ (1.016 mm) 0.003″ (0.0762 mm), as shown in FIG.25K. The dome 2239′″ comprises a wall thickness with variable rangesshown in FIG. 25O, though alternate embodiments can include thinner orthicker wall thicknesses, e.g., in the dome portion of the valve.

FIGS. 26A-28Q illustrate alternative embodiments of the valveconstructed according to embodiments of the disclosed inventions. Theshunt includes at least one valve, as shown, for example, in FIGS.15A-C. The valve regulates the rate of CSF flow through the shunt, whileallowing flow of CSF only in one direction, i.e., from the distalportion of the shunt located in the subarachnoid space to the proximalportion of the shunt located in the venous anatomy. Features, functions,and configurations of the valve of FIGS. 26A-28Q that are the same as inthe valve of the present disclosure (e.g., FIGS. 25A-O) and in therelated application, are incorporated by reference herewith, thedifferences will be described in further detail below. The valve mayhave a variety of suitable features, such as comprising a moldedsilicone element configured to be coupled to the shunt in fluidcommunication with the shunt lumen. For example, the valve 2209″ ofFIGS. 26A-D is a one-way valve having a cylindrical body comprising avalve lumen 2237 and an end portion dome 2239. The valve 2209″ includesa transitional core 2236 (e.g., inner tapered surface of the dome 2239),as better appreciated in the cross-sectional portion of the dome (FIG.26B). By contrast, the valve 2209″ of FIGS. 27A-D include anon-transitional core 2235 (e.g., inner square or flat inner surface ofthe dome 2239), as better appreciated in the cross-sectional portion ofthe dome 2239 (FIG. 27B). Either valve 2239″, having transitional (FIGS.26A-D) or non-transitional (FIGS. 27A-D) cores 2236 or 2235,respectively, include cuts, slits, holes, perforations or the like(FIGS. 28A-Q) configured to open the valve 2209″ and allow for fluidcommunication facilitating CSF flow through the shunt when deployed inthe target site.

FIGS. 28A-Q illustrate exemplary valve cuts at the end portion dome 2239of the valves 2209″ constructed according to embodiments of thedisclosed inventions. The dome 2239 may be cut to include two or moreleaflets 2290 formed from cutting or slitting, as shown in FIGS. 28A,28C-E and 28I. The leaflets 2290 may be similar to a heart valve, asshown in FIGS. 25E and 25H. Alternative the cuts at the end portion dome2239 may not form leaflets, such as when linear cuts do not intersect2291, as better appreciated in FIGS. 28B and 28F-H. Thesenon-intersecting cuts 2291 of the dome 2239 allow for opening of thevalve 2209″ while also allowing the valve 2209″ to fully close.

FIG. 28J-Q illustrate further exemplary valve cuts at the end portiondome 2239. In contrast with the linear cuts of FIGS. 28A-I, FIGS. 28J-Qshows arcuate, circular-shaped, concave and convex cuts or the like,that may extend along the cylindrical body of the valve 2209″ formingtwo or more leaflets 2290.

FIG. 29 illustrates valve embodiments that include an internal supportmember and exterior layer. For example, valve 2209 can include arelatively rigid internal support member 2219 comprising a gold (orother radiopaque metal or alloy), Nitinol, stainless steel, or polymerichypotube (e.g., any of the polymers previously described herein ordisclosed in the applications incorporated by reference). The internallumen of the support member 2219 provides the shunt lumen 207 for aproximal portion of the shunt and can comprise the entire length of theshunt lumen in other embodiments. As shown in FIG. 29, the supportmember 2219 can include one or more apertures (e.g., four apertures 2221as shown in the figure). Exterior layer 2220 can include a silicone,polyurethane, or other suitable polymeric material hypotube or layerdisposed concentrically over the internal support member 2219. Theproximal ends of internal support member 2219 and the exterior layer2220 can be closed as depicted in the FIG. 29. Exterior layer 2220 caninclude one or more slits 2241 (e.g., slit created by a blade or trocar)or apertures 2243 (e.g., apertures created by a laser that removes aportion of the layer material between the opposing edges of theaperture). The rotational or clocking orientation of the exterior layer2220 and slits or apertures 2243 can be varied with respect to thelocation of the apertures 2241 of the internal support member 2219(e.g., indicated by the “C” arrows in the FIG. 29) to achieve a targetcracking pressure in these alternate valve 2209. As will be furtherdescribed below, aspects of the valve 2209 of FIG. 29 allow CSF withinshunt lumen 207 to flow through the apertures 2221 of the internalsupport member 2219, between the respective outer surface of theinternal support member and inner surface of the exterior layer, and outof the slit 2241 or aperture 2243 of exterior layer 2220.

Where exterior layer comprises one or more slits 2241, the opposingedges of the slit(s) provide a sealing interface to maintain the valve2209 closed below a target opening or cracking pressure. When the shuntlumen 207 and/or internal support fill with CSF and meet or exceed thecracking or opening pressure of the valve 2209, the one or more slits2241 of the exterior layer 2220 open to allow CSF to flow from shuntlumen 207 and out from the valve 2209. In backpressure conditions (e.g.,venous blood pressure exceeds intracranial pressure), the slits 2241seal to prevent blood from entering the shunt lumen 207. Support member2219 resists compression or collapse of the exterior layer in suchbackpressure conditions.

The relative sizing between internal support member 2219 and exteriorlayer 2220 (e.g., referenced as “AD” in FIG. 29) can be optimized totarget a valve cracking pressure, facilitate CSF flow from withininternal support member 2219/shunt lumen 207 and through the exteriorlayer 2220 and out of the valve 209, and prevent backlow. For example,in embodiments where exterior layer 2220 includes one or more slits2241, the difference between the outer diameter of internal supportmember 2219 and the inner diameter of exterior layer 2220 can be about0.0001″ to 0.005″ (0.00254 mm to 0.127 mm). In embodiments whereexterior layer 2220 includes one or more apertures 2243, the outerdiameter of the internal support member 2219 can be sized more closelyto or slightly exceed the inner diameter of exterior layer 2220. In suchembodiments, the external and internal diameters of the internal supportand exterior layer, respectively, can provide a sealing interface toprevent fluid flow below a target cracking pressure and in backpressureconditions; once CSF pressure within shunt lumen 207 and/or internalsupport member 2219 meet or exceed a target cracking pressure, CSF flowsthrough the one or more apertures 2243 of the internal support and outthrough the one or more apertures 2243 of the exterior layer 2220. Infurther embodiments comprising one or more slits in the exterior layer2220, the inner diameter of such exterior layer 2220 can match the outerdiameter of the internal support member 2219; in such embodiments, theexterior layer 2220 will seal against the internal support at the pointswhere the respective inner and outer diameters touch below a targetcracking pressure. Where the target cracking pressure is met orexceeded, CSF flows through the one or more apertures of the internalsupport 2219 and out through the one or more slits 2241 of the exteriorlayer 2220.

FIGS. 30A-G illustrate an alternative delivery catheter for deliveringthe shunt into a target site of a patient, constructed in accordancewith embodiments of the disclosed inventions. For ease in illustrationand disclosure, the features, functions, and configurations of thedelivery catheter that are the same as in the catheter of FIGS. 10A-Kand in the related application, are incorporated by reference herewith;the differences will be described in further detail below. FIG. 30A showperspective longitudinal side views at various points along thelongitudinal axis of the delivery catheter. FIG. 30B shows anotherperspective longitudinal cross-sectional views of the delivery catheter.The delivery catheter 3304 of FIGS. 30A-E includes a penetrating element3350 on the distal portion and a distinct radiopaque marker band 3354proximately disposed to the penetrating element 3350. The radiopaquemarker band 3354 may be disposed in an angle with respect to thelongitudinal axis of the catheter 3304 to indicate direction/orientationof the catheter distal portion 3344 during delivery of the shunt at thetarget site. The angled marker 3354 may further include directionalfeatures, such as arrow heads, or the like, as shown in FIGS. 31A-G.

Further to the shunt lumen and the elongated guide member lumen, asshown in FIG. 10C as 3305 and 3315 respectively, the delivery catheterof FIG. 30A includes an additional lumen (FIGS. 30D and 30E) adjacentlydisposed to the shunt lumen. The additional lumen is configured to allowpassage of the guard pull wire, the penetrating element guard, anadditional penetrating element, tool, or any other suitable element.

The shunt delivery catheter 3304 includes a reinforcing member 1345(FIGS. 30A-B, FIGS. 30F-G) configured to reinforce the catheter 3304while providing a suitable balance between column strength andflexibility (e.g., “pushability” and “torqueability”). The reinforcingmember 1345 is composed of suitable biocompatible and/or elastomericmaterials such as, stainless steel, Nitinol® or the like. Thereinforcing member 1345 includes a plurality of cuts 1330 (e.g., kerfs,slots, key-ways, recesses, or the like) selectively disposed in sectionsof the reinforcing member 1345 along length L₂₀ of the delivery catheter3304, as shown in FIGS. 30A-B, and FIG. 30F. Alternatively, the cuts1330 can be continuously disposed substantially along L₂₀ (not shown).It should be appreciated that the cuts 1330 can have variable spiral cutpatterns of kerf, pitch, cuts per rotation and cut balance along L₂₀ orcombinations thereof. Additionally, the reinforcing member 1345 of FIGS.30A-G includes an inner liner 1360 and an outer jacket 1365 (FIG. 30B),as previously described and better appreciated in detail in FIG. 12C.The inner liner 1360 and outer jacket 1365 are configured tocover—substantially completely or partially—the cuts 1330 of thereinforcing member 1345, while maintaining the flexibility provided bythe selective cuts 1330 and column strength afforded, in part, by thereinforcing member 1345.

The distal portion of the delivery catheter 3344 of FIGS. 30A-B and FIG.30F, further includes a stain-relief portion 3343 element proximatelydisposed to the penetrating element 3350 to avoid, minimize and/orresist kinking of the catheter 3304 at the transition area from theflexible portion of the catheter to the penetrating element, duringpenetration of the IPS wall and delivery of the shunt. Further, theselective cuts along the length of the delivery catheter are configuredto provide a balance between column strength and flexibility of thecatheter, such as, having a more rigid proximal portion to a moreflexible distal portion (FIGS. 30A-C).

FIGS. 31A-G illustrate an alternative marker, constructed in accordancewith embodiments of the disclosed inventions. The marker 3354 iscomposed of radiopaque material and may be formed by cutting a tubularelement in an angle, as shown for example in angle A₃₀ of FIG. 31A.Additionally, the marker 3354 may include any other relative size,geometry or configurations (e.g., arrow head, different width of theband, asymmetric band, or the like) suitable to indicate directionand/or orientation of the element where the marker is disposed, such asfor example, when the marker is disposed on the delivery catheter toindicate the direction of the penetrating element. FIGS. 31D-E aredetailed views of respective edges 3354′ and 3354″ of the marker of FIG.31C.

FIG. 32 illustrates a shunt constructed and implanted according toembodiments of the disclosed inventions. FIG. 32 illustrates yet anotherexemplary shunt 2200 constructed and implanted according to embodimentsof the disclosed inventions. For ease in illustration and disclosure,the features, functions, and configurations of the shunt 2200 that arethe same as in the shunt of the present disclosure (e.g., FIGS. 15A-J,22A-24F) and in the related application, are incorporated by referenceherewith; the differences will be described in further detail below. Theimplanted shunt 2200 of FIG. 32 shows three distinct zones; zone I(Distal) depicts the distal portion 2202 of the shunt having the distalanchoring mechanism 2229 engaging the dura mater IPS wall 114, thearachnoid layer 115 and/or securing the shunt 2200 at the target site(e.g., subarachnoid space, CP angle cistern 138), zone II (Mid) depictsthe middle or body portion 2203 of the shunt disposed within the IPS 102and zone III (Proximal) depicts the proximal portion 2204 of the shunthaving the proximal anchoring mechanism 2227 engaging and/or securingthe shunt in the venous system (e.g., IPS 102, jugular vein 106, and/ora jugular bulb 108). In some shunt embodiments (e.g., FIGS. 53, 54A,56A-58F), zone III (Proximal) does not include an anchoring mechanismand the proximal portion 2204 of the implanted shunt is disposed in theIPS 102, jugular vein 106, and/or a jugular bulb 108. The zone I(Distal) is configured to maintain a patent fluid inlet, zone II (Mid)is configured to accommodate a variety of IPS anatomies (e.g., length,curvature, width, or the like), maintain a patent fluid lumen (e.g.,kink-resistant, non-thrombogenic, protein resistant, or the like), oralternatively function as an anchor within the IPS. Zone III isconfigured to minimize or prevent thrombus formation on the implantedshunt, maintain valve patency, and/or further maintain the valve 2209separated from the vessel wall to prevent encapsulation (e.g., 2-3 mmaway from the wall). FIGS. 33A-40C illustrate exemplary embodiments ofzones I-Ill of the shunt 2200 according to the disclosed inventions. Itshould be appreciated that the shunt 2200 constructed according toembodiments of the disclosed inventions may include any variety orcombinations of zones I-Ill as disclosed herein and/or in the relatedapplication that are incorporated by reference herewith.

FIGS. 33A-40C illustrate exemplary embodiments of zone I (Distal) of theshunt, according to the disclosed inventions. FIGS. 33A-C illustrates adistal portion 2202 of the shunt 2200 including a double-malecotanchoring mechanism 2229 in a deployed expanded configuration. Thedouble-malecot includes a proximal malecot 2229-1, a distal malecot2229-3 and a joint element 2229-2 (e.g., collar, band—FIGS. 33A-B—,struts with hinge members—FIG. 33C— or the like) disposed therebetween.The double-malecot is configured to expand into the deployedconfiguration engaging the arachnoid layer 115 at the CP angle cistern138 and the dura layer 114 at the IPS 102. The double-malecotconfiguration of the distal anchoring mechanism 2229 further secures thedistal portion 2202 of the implanted shunt 2200, while avoiding orminimizing distal or proximal migration/translation of the shunt 2200.Additionally, the double-malecot distal anchoring mechanism 2229 mayfurther include a liner 2229-4 (e.g., membrane, mesh, braid or othersuitable permeable material or combinations thereof), as shown in FIGS.33B-C, configured to avoid or minimize the formation of thrombus.

FIGS. 34-35 illustrate distal portions 2202 of the shunt including amalecot-flarecot anchoring mechanism 2229 in a deployed expandedconfiguration. The malecot portion is configured to expand into thedeployed configuration engaging the arachnoid layer 115 at the CP anglecistern 138 and the flarecot is configured to engage the dura mater 114at the IPS 102. The flarecot arms 2229 a of the malecot-flarecotanchoring mechanism 2229 can flare out in the distal direction (e.g.,towards the dura mater 114 in the implanted shunt), as shown in FIG. 34or the flarecot arms 2229 a can flare out in the proximal direction(e.g., towards the IPS 102 in the implanted shunt), as shown in FIG. 35,or the flarecot arms 2229 a may comprise a combination of the arms 2229a of FIGS. 34 and 35. Similar to the double-malecot configuration, thezone I (Distal) embodiments of FIGS. 34-35 further secure the distalportion 2202 of the implanted shunt 2200, while avoiding or minimizingdistal or proximal migration/translation of the shunt.

FIG. 36 illustrates a distal portion 2202 of the shunt including amalecot anchoring mechanism 2229 in a deployed expanded configuration.The malecot anchoring mechanism further includes an annular element2229-5 composed of expandable material (e.g., foam, swellable or thelike). The annular element 2229-5 is configured to expand when disposedwithin an anastomosis channel formed by piercing the IPS wall 114 andarachnoid layer 115, and further secure the shunt 2200 at the targetsite.

FIGS. 37-39B illustrate distal portions of embodiments of the shunt 2200including anchoring mechanisms 2229 in a deployed expandedconfiguration. The anchoring mechanism 2229 is composed of polymericmaterial, such as silicone, or any other suitable biocompatiblenon-metallic materials. The anchoring mechanism 2229 includes anexpandable element that may have a spheroid, ellipsoid, obloid,diamond-like (FIGS. 37-38), funnel-like (FIGS. 39A-B) or any othersuitable shape and dimension configured to anchor the shunt 2200 at thetarget site when expanded. In some embodiments, the distal anchoringmechanism 2229 includes one expandable element, as shown in FIGS. 37 and39A-B. In other embodiments, the distal anchoring mechanism includes atleast two expandable elements and a portion therebetween, as shown inFIG. 38. The distal anchoring mechanisms 2229 of FIGS. 37-39B furtherinclude a one-way valve 2209, which functions as the valves previouslydescribed herein (e.g., FIGS. 25A-28Q).

FIGS. 40A-C illustrate another embodiment of the distal portion of theshunt having an anchoring mechanism 2229 in a deployed expandedconfiguration. The anchoring mechanism 2229 of FIGS. 40A-B includes amalecot and polymeric cover 2229-4; the polymeric cover 2229-4 furtherincludes a plurality of leaflets 2290. In one embodiment, the polymericcover 2229-4 is composed of urethane, and the leaflets 2290 are composedof silicone. It should be appreciated that any other suitablebiocompatible materials may be used in the distal anchoring mechanisms2229. The leaflets 2290 are configured as one-way valve, and function asthe valves previously described. The leaflets 2290 may further increasethe functional valve area, as shown in FIGS. 40A-B. The anchoringmechanism of FIG. 40C includes a double-malecot and polymeric cover2229-4 having a plurality of leaflets 2290 acting as one-way valve 2209.

FIGS. 41A-48B illustrate exemplary embodiments of zone II (Mid) of theshunt, according to the disclosed inventions. FIG. 41A illustrates anelongated tubular member 2203 having a proximal portion (not shown), adistal portion 2203 a, and a lumen 2207 (FIGS. 41A-B) extendingtherebetween. FIG. 41B is a cross-sectional view of FIG. 41A. Theelongated tubular member 2203 of FIGS. 41A-B is configured to becompressed and/or stretch during delivery of the shunt 2200. Theelongated tubular member 2203 of FIGS. 41A-B is composed of silicone andis formed by extrusion. In other embodiments, the elongated tubularmember 2203 of zone II (Mid) of the shunt 2200 can be composed of anyother suitable biocompatible polymeric material including, for example,polyurethane or silicone-polyurethane blend, and can be formed by anysuitable technique.

FIG. 42A illustrates the elongated tubular member 2203 of FIGS. 41A-Bhaving an embedded coil element 22031. The coil element 22031 can becomposed of any suitable polymeric, metallic material or combinationthereof. The coil element 22031 provides reinforcement (e.g., increasedcolumn strength) and kink resistance to the zone II (Mid) of the shunt.FIG. 42B is a cross-sectional view of FIG. 42A.

FIG. 43A illustrates the elongated tubular member 2203 of FIGS. 41A-Bhaving an embedded tubular element 22032. The embedded tubular element22032 can be composed of any suitable materials, such as, platinum,Nitinol®, gold or other biocompatible materials. The embedded tubularelement 22032 provides reinforcement (e.g., increased column strength)and kink resistance to the zone II (Mid) of the shunt. Further, theembedded tubular element 22032 includes a plurality of cuts along thelength configured to increase flexibility of the element. FIG. 43B is across-sectional view of FIG. 43A.

FIGS. 44A-48B illustrate the elongated tubular member 2203 of FIGS.41A-B having one or more spine elements 22033. The spine element 22033can be composed of any suitable materials, such as, platinum, Nitinol®,gold or other biocompatible materials. The spine element 22033 isconfigured to provide reinforcement (e.g., increased column strength)and kink resistance to the zone II (Mid) of the shunt. In someembodiments, the spine element 22033 can be used as shunt shapingstylets. The spine element 22033 can be an elongated rod or cylindricalmember (FIGS. 44A-B, 46A-B), an arcuate elongated member (FIGS. 45A-B),a flat elongated member (FIGS. 48A-B), or can have any other suitableconfiguration. In the embodiments of FIGS. 44A-B, the spine element22033 is disposed in the lumen 2207 of the tubular element, such asconcentrically disposed (FIGS. 44A-B) or laterally disposed (FIGS.45A-B). In the embodiments of FIGS. 46A-48B, a plurality of spineelements 22033 is embedded in the tubular element 2203. FIGS. 44B-48Bare a cross-sectional view of the respective FIGS. 44A-48A.

FIGS. 49A-B illustrate exemplary embodiments of zone III (Proximal) ofthe shunt according to the disclosed inventions. Additionally, FIGS.49A-B illustrate deployed shunts 2200 having previously disclosed zonesI and II, in combination with zone III of the shunt that will bedescribed below. As shown in FIGS. 49A-B, the proximal anchoringmechanism 2227 includes an expandable member and having a bulb-likeconfiguration. The proximal portion 2204 of the shunt further includes avalve 2209 proximally disposed to the anchoring mechanism 2227 (e.g., atthe tip of the conical proximal end and/or the valve being formed byslits on the bulb-like anchoring mechanism). FIGS. 49A-B are perspectiveviews of the shunt; the shunt further having the elongated tubularmember 2203 of FIGS. 41A-B in zone II, and the malecot-flarecotanchoring mechanism 2229 of FIG. 35 in zone I.

FIGS. 50A-C illustrate another exemplary embodiment of zone III(Proximal) of the shunt having a proximal anchoring mechanism 2227. Asshown in FIGS. 50A-B, the proximal anchoring mechanism 2227 includes aspine composed of shape memory material, such as Nitinol®, or othersuper-elastic alloys, configured to form a loop when the shunt isdeployed. The spine can be configured to adjust the direction of CSFoutflow from the deployed shunt device. For example, as shown in FIG.50B, the spine is configured to form a coil in zone III (Proximal) ofthe shunt with CSF outflow antegrade to the venous blood flow of theIJV; the valve 2209 shown in the FIG. 50B faces the direction of bloodflow in the IJV. The proximal anchoring mechanism 2227 of FIGS. 50A-B isconfigured to maintain valve patency and further maintain the valve 2209separated from the vessel wall to prevent encapsulation. FIGS. 50A-C areperspective views of the shunt 2200; the shunt further having theelongated tubular member of FIGS. 45A-B or 46A-B in zone II, and asingle malecot-liner distal anchoring mechanism in zone I, as betterappreciated in FIG. 50C.

FIGS. 51A-C illustrate yet another exemplary embodiment of zone III(Proximal) of the shunt having a proximal anchoring mechanism 2227. Asshown in FIGS. 51A-B, the proximal anchoring mechanism 2227 includes aplurality of spine elements 22033 composed of shape memory material,such as Nitinol®, or other super-elastic alloys, configured to form acoil when the shunt is deployed. Similar to the embodiments of FIGS.50A-B, the proximal anchoring mechanism 2227 of FIGS. 51A-B isconfigured to maintain valve patency and maintain the valve 2209separated from the vessel wall to prevent encapsulation. FIGS. 51A-C areperspective views of the shunt; the shunt further having the elongatedtubular member 2203 of FIGS. 46A-B or 47A-B in zone II, and the malecotdistal anchoring mechanism 2229 of FIG. 36 in zone I.

FIGS. 52A-C illustrate another exemplary embodiment of zone III(Proximal) of the shunt 2200. As shown in FIGS. 52A-B, the zone III(Proximal) includes the configuration of the elongated tubular element2203 of zone II (Mid) of FIG. 41A-B. FIGS. 52A-C are perspective viewsof the shunt 2200; the shunt having the elongated tubular member 2203 ofFIGS. 41A-B in zone 2, and the anchoring mechanism 2229 of FIG. 38 inzone 1. In the embodiments of FIGS. 52A-C the one-way valve 2209 isdisposed in the distal anchoring mechanism 2229.

FIG. 53 illustrates the embodiment of zone III (Proximal) of the shunt2200 of FIGS. 52A-B having the distal anchoring mechanism 2229 of FIG.40C.

FIGS. 54A-B illustrates the embodiment of zone III (Proximal) of FIGS.52A-B having the distal anchoring mechanism 2229 of combined FIGS. 36with 39A-B.

FIGS. 55A-O illustrate an exemplary shunt implant procedure in a patientsuffering from elevated intracranial pressure. Any of the foregoingshunt and delivery system embodiments described herein can be used inthe following exemplary procedure. The clinician can obtain CT and/orMRI imaging (e.g., coronal, T2, thin cut MRI images with gadoliniumcontrast) studies of the patient's intracranial anatomy to ascertain thesizing and relative proximity between the patient's right IPS 102R andleft IPS 102L, CP angle cistern 138, arterial structures (e.g., basilarartery), and surrounding bony anatomy; such imaging can also be used toassess the volume of unobstructed CSF space of CP angle cistern 138surrounding the left and right IPS channels relative to a targetpenetration site 5000 in an IPS 102 where an anastomosis will be madeduring the shunt implant procedure. The clinician can use thispre-procedure imaging to select one or more preferred shunt deploymentlocations along the first curved portion 102A and/or second curvedportion 102B in the patient's right IPS 102R and/or left IPS 102L. Tofurther illustrate the following exemplary procedure, the clinicianselects the patient's right IPS 102R and a target penetration site 5000along the first curve 102A of the IPS based on the pre-procedure MRIimaging study, as shown in FIG. 55A.

The clinician gains access to the patient's venous vasculature throughthe patient's right femoral vein using an introducer kit (e.g.,Micropuncture Introducer Set from Cook Medical of Bloomington, Ind.) andthe Seldinger technique. The clinician then navigates a guide wire(e.g., 0.035″ guide wire such as an 0.035″ GLIDEWIRE from TerumoInterventional Systems of Somerset, N.J.) and a guide catheter 307(e.g., 6 Fr catheter such as 6Fr ENVOY Guiding Catheter from CodmanNeuro of Raynham, Mass.) through the femoral vein access point, distallythrough the vena cava and into the right jugular vein. The clinician canposition the distal end of the guide catheter 307 about the JV-IPSjunction 118 as shown in FIG. 55A, and in certain patient anatomies, thedistal end of the guide catheter can access the proximal portion of theIPS 102. Optionally, a shuttle sheath (e.g., 7Fr Flexor Shuttle GuidingSheath from Cook Medical of Bloomington, Ind.) may be advanced throughthe patient's venous vasculature, prior to advancing the guide catheter307; the guide catheter 307 can then be advanced through the shuttlesheath lumen to the jugular vein or JV-IPS junction 118. The shuttlesheath can provide additional support to the guide catheter, othercatheter and guide wire components navigated to IPS 102 during the shuntprocedure.

Then, the clinician accesses the right IPS 102R and/or cavernous sinus104 with a micro catheter 3307 and micro wire 3333 (FIGS. 55B and 55C).The micro catheter 3307 (e.g., an 0.027″ micro catheter such as a Phenom27 Catheter from Cathera, Inc. of Mountain View, Calif., an ExcelsiorSL-10 Micro catheter from Stryker Neurovascular of Fremont, Calif., or aMarksman Micro Catheter from Medtronic of Irvine, Calif., any of the0.027″ micro catheter embodiments disclosed in U.S. Provisional PatentApplication No. 62/466,272) advances through the guide catheter lumen,and the micro wire (e.g., an 0.010″, 0.014″, or 0.018″ guide wire suchas a Synchro2 Guidewire from Stryker Neurovascular of Fremont, Calif.)can pass through the micro catheter lumen. The clinician advances themicro wire 3333 and micro catheter 3307 through the JV-IPS junction 118into the right IPS 102R (e.g., the micro wire 3333 may be advanceddistally and incrementally, followed by the micro catheter 3307advancing distally and incrementally over the micro wire 3333, repeatingthe wire and catheter advancement steps in serial fashion; the microwire may be advanced to its distal location first with the microcatheter following thereafter in two separate advancements; or the microwire and micro catheter can be advanced distally, simultaneously throughthe JV-IPS junction 118 and into the right IPS 102R). The clinician canposition the distal end of the micro catheter 3307 at a location distalto the target penetration site 5000 in IPS wall 114 along first curve102A of the right IPS 102R as shown in FIG. 55C. The clinician withdrawsthe micro wire 3333 from the micro catheter 3307, leaving the distalopening 3317 of the micro catheter 3307 distal to the target penetrationsite 5000 in IPS wall 114 along first curve 102A of the right IPS 102R,as shown in FIG. 55C.

The clinician then deploys an anchor 700 and guide member 780 in thedistal portion of the right IPS 102R in step S020 of the procedure,which results in the anchor 700 secured in IPS 102R, distal to thetarget penetration site along IPS wall 114 of the first curved portion102A of the right IPS 102R as shown in FIG. 55E. The clinician can loadthe anchor 700 and elongate guide member 780 into the proximal opening(not show) of the micro catheter 3307. Using elongated pusher of FIGS.13, 14A-E and by loading the proximal portion 784 of guide member 780through the pusher lumen 3724 as previously disclosed, the clinicianadvances anchor 700 and guide member 780 distally through the microcatheter lumen until the anchor 700 reaches the distal opening 3317 ofthe micro catheter lumen as shown in FIG. 55D. The elongated guidemember 780 may be disposed within the lumen 3724 of the elongated pusher3710 (FIGS. 13, 14A-E) for delivering the anchor 700 into the IPS 102,while the proximal portion 784 of guide member 780 extends out theelongated pusher 3710 (e.g., out through the lumen opening 3726′ ofhandle 3722), as previously described. A clinician can pinch or hold theproximal portion 784 of guide member 780 extending through the handle3722 against the handle outer surface 3725 and then advance the handle3722 and guide member 780 into a micro catheter to advance the anchor700 distally. The clinician can then retract elongated pusher 3710proximally over the proximal portion 784 of guide member 780 (i.e., byreleasing the proximal portion 784 of guide member 780 pinched or heldagainst the handle outer surface 3725), and thereafter repeat theadvancing and retracting acts until the anchor 700 reaches a desiredlocation (e.g., distal end of micro catheter lumen). The use of theelongated pusher 3710 facilitates the anchor 700 delivery and navigationby leveraging the column strength of guide member 780, as an alternativeto having an anchor pusher member that extends at least the length ofthe micro catheter.

The clinician then positions the distal portion of the micro catheter3307 (i.e., with anchor 700 and guide member 780 packed inside) aboutthe location for anchor deployment, and withdraws the micro catheter3307 proximally while holding the anchor 700 in place using guide member780 and/or advances anchor 700 via guide member 780 distally through thedistal opening 3317 of the micro catheter 3307 while holding the microcatheter 3307 in place until the anchor 700 emerges from the catheterlumen and expands against the walls of the sinus lumen. At this point ofthe procedure, a distal portion of guide member 780 such as joint 744coupling the guide member and anchor 700, can be disposed in the sinuslumen; the remainder of guide member 780 remains within the microcatheter lumen. If the clinician is satisfied with the anchor deploymentlocation, he then withdraws the micro catheter from the patient, leavingbehind the deployed anchor 700 with guide member 780 that extendsproximally from the proximal portion of anchor 700 through the firstcurved portion 102A and junction 118 as shown in FIG. 55E, through thepatient's venous vasculature and out of the patient via the femoral veinaccess point. Alternatively, he can recapture the deployed anchor 700and guide member 780 into the micro catheter lumen and redeploy theanchor in the sinus lumen one or more times until he is satisfied withthe anchor deployment location. Optionally, the clinician can useelongated pusher 3710 with micro catheter 3307 to facilitate anchor 700recapture and redeployment in the sinus lumen.

To continue the procedure, the clinician introduces delivery catheter3304 into the patient's vasculature via the femoral vein access pointand navigates the catheter 3304 distally through the JV-IPS junction 118(as shown in FIG. 55F) to the target penetration site 5000 along IPSwall 114 of the first curved portion 102A of the right IPS 102R. Theclinician can feed the proximal end of guide member 780 through thefirst lumen 3315 of delivery catheter 3304, via distal opening 3315 aand proximal opening 3315 b of the first lumen. The clinician thenadvances delivery catheter 3304 over guide member 780, through thefemoral vein access point and tracks the delivery catheter 3304distally, over the guide member 780 and through the patient's venousvasculature, until the distal portion 3344 of the delivery catheter 3304is positioned about the target penetration site 5000 along IPS wall 114of the first curved portion 102A of the right IPS 102R as shown in FIG.55G. While tracking the delivery catheter 3304 distally, the cliniciancan hold the guide member 780 stationary or pull proximally on theproximal portion 784 of the guide member 780 to facilitate advancementof the delivery catheter 3304 through the patient's venous anatomy. Inaddition, the clinician can rotate the delivery catheter 3304 whiletracking distally over the guide member 780 to overcome any resistance,e.g., resistance encountered while tracking the catheter through JV-IPSjunction 118 and/or into right IPS 102R.

The clinician can confirm the orientation of the delivery catheter 3304and the trajectory of penetrating element 3350 through IPS wall 114 intoCP angle cistern 138 relative to the target penetration site 5000 usingone or more of the previously disclosed imaging techniques. Theclinician may use the distal 3354 a and proximal 3354 b markers locatedon the distal portion 3344 of the delivery catheter 3304 in thisconfirmation step. The markers will be visible under various imagingmodalities used during the procedure (e.g., bi- or single-planefluoroscopy). To the extent the clinician has created a 3Dreconstruction of the patient's anatomy about the target penetrationsite 5000 (e.g., using 3D-rotational angiography or venography), theclinician can confirm the orientation and/or trajectory of thepenetrating element 3350 by combining the fluoroscopy and 3Dreconstruction using a 3D road mapping technique. Optionally, theclinician can use the 3D reconstruction data to create a windowrepresenting the target penetration site 5000; the 3D window and livefluoroscopy can be overlaid with respect to each other to providefurther guidance for the clinician to penetrate IPS wall 114 at targetpenetration site 5000.

Then, the clinician retracts the penetrating element guard or guardmember 4000 to expose penetrating element 3350 in the IPS 102 at thetarget penetration site along IPS wall 114 of the first curved portion102A of the right IPS 102R as shown in FIG. 55H. The clinician retractsthe guard member 4000 by pulling proximally on pull wire 4010 whileholding the remainder of delivery catheter 3304 in place. Whileretracting guard 4000 and using the previously disclosed imagingtechniques, the clinician will observe marker 4015 in guard 4000transition proximally towards and/or until it abuts or overlaps withdistal marker 3354 a located on the distal portion 3344 of deliverycatheter 3304. Again, the clinician can confirm the trajectory ofpenetrating element 3350 through the IPS wall 114 into CP angle cistern138 using one or more of the previously disclosed imaging techniquesbefore penetrating IPS wall 114. If the clinician is unsatisfied withthe trajectory of the penetrating element 3350 or perceived penetrationsite 5000 on IPS wall 114, the clinician can adjust the location of thedistal portion 3344 of delivery catheter 3304 until the clinician issatisfied that penetrating element 3350 will penetrate the IPS wall 114at the target location along the first curved portion 102A of the rightIPS 102R. When adjusting the location of the distal portion 3344 ofdelivery catheter 3304 the clinician can re-sheath penetrating element3350 by advancing the penetrating element guard 4000 distally via pullwire 4010 and then unsheath penetrating element by retracting guard 4000proximally before penetrating IPS wall 114; this re-sheathing step canprevent inadvertent penetration or injury to the IPS walls that couldoccur if the penetrating element 3350 were uncovered or unprotectedwhile the clinician repositioned delivery catheter 3304 in the IPS 102.

With the penetrating element 3350 oriented along a desired trajectory atthe target penetration along IPS wall 114, the clinician advancesdelivery catheter 3304 distally so that penetrating element 3350 passesthrough the dura of IPS wall 114, arachnoid layer 115, and into theCSF-filled subarachnoid space of CP angle cistern 138 as shown in FIG.55I. The clinician can pull proximally on the proximal portion of guidemember 780 or hold the guide member 780 in place while advancingdelivery catheter 3304 distally to cause the penetrating element 3350 topenetrate the IPS wall 114; these techniques allow the portion ofdelivery catheter 3304, distal of the lumen opening 3315 a to trackalong the target trajectory and off-axis from the path of guide member780 through the first curved portion 102A of the right IPS 102R. Theclinician stops advancing delivery catheter 3304 distally when theclinician is satisfied that penetrating element 3350 and second lumen3305 of delivery catheter 3304 have accessed CSF of the CP angle cistern138; this can be confirmed via one or more of the previously disclosedimaging techniques, e.g., by 3D road mapping.

As an alternative method of confirming access to CP angle cistern 138,the clinician can aspirate CSF through the penetrating element 3350 andsecond lumen 3305 of delivery catheter 3304 to confirm that thepenetrating element 3350 passed through IPS wall 114 and arachnoid layer115 to access CSF within CP angle cistern 138 (e.g., aspirated CSFdenoted by arrow-head lines in FIG. 55J). The clinician can use asyringe on the distal portion of handle (e.g., 10 cc syringe) toaspirate CSF proximally, through delivery catheter 3304. The presence ofclear CSF in the syringe can confirm a successful penetration throughthe IPS into the CP angle cistern 138. If the clinician observes bloodin the syringe, this can indicate that the penetrating element 3350 didnot completely pass through IPS wall 114 or remained entirely withinright IPS 102R. If the clinician did not penetrate IPS wall 114, theclinician can re-attempt to penetrate IPS wall 114 at the target site,attempt to penetrate IPS wall 114 at another target penetration sitealong the first curved portion 102A of right IPS 102R, attempt topenetrate IPS wall 114 along the second curved portion 102B of right IPS102R as will be further described below, or abort the procedure.

After confirming that the penetrating element 3350 passed through IPSwall 114 and arachnoid layer 115 to access CSF within CP angle cistern138, the clinician advances pusher member 3310 distally to advance shunt200 distally from the lumen 3305 of delivery catheter 3304 until thedistal anchoring mechanism 229 of the shunt deploys in CP angle cistern138 in step S050 of the procedure as shown in FIG. 55K. The cliniciancan confirm that the distal anchoring mechanism 229 of the shuntdeployed in the cistern by observing a radiopaque marking(s) on a distalportion of the shunt as it emerges from the catheter into thesubarachnoid space, using one the previously disclosed imagingtechniques (e.g., by using live fluoroscopy to observe the RO makings inthe distal portion of the shunt transition from a delivery configurationto a deployed configuration as described in connection with FIG. 55C).By pulling shunt pusher 3310 proximally (and, optionally, simultaneouslypulling delivery catheter 3304 proximally), the clinician fully expandsthe distal anchoring mechanism 229 against arachnoid layer 115 in CPangle cistern 138.

The clinician continues deploying shunt 200 across the penetration tractin IPS wall 114 and in the right IPS 102R in step S055 of the procedureas shown in FIG. 55L. By holding shunt pusher member 3310 in place whilewithdrawing delivery catheter 3304 proximally, shunt 200 emerges fromthe delivery catheter lumen 3305 and deploys in the lumen of IPS 102R.At this point in the procedure, the proximal portion of shunt 200 and,if included on the particular embodiment of shunt 200 being deployed,proximal anchoring mechanism 227 on the shunt remain inside lumen 3305of delivery catheter 3304; the remainder of the shunt is deployed in theCP angle cistern and right IPS 102R.

The clinician finishes deploying shunt 200 in step S060 of the procedureby deploying proximal anchoring mechanism 227 of shunt 200 about theJV-IPS junction 118 or in jugular vein 106 as shown in FIG. 55M. Again,by holding shunt pusher member 3310 in place while withdrawing deliverycatheter 3304 proximally, shunt 200 emerges from delivery catheter lumen3305. As the proximal anchoring mechanism 227 and interlocking elements229 on the distal portion of the shunt pusher member 3310 emerge fromwithin the delivery catheter lumen 3305, the shunt pusher member andshunt separate or disconnect, thereby releasing shunt 200 from pushermember 3310. The clinician, optionally, can pause the shunt deploymentstep before the shunt completely releases from the interlock (or theself-expanding distal end portion of the shunt delivery shuttledisclosed herein) of pusher member 3310 by holding delivery catheter3304 in place (e.g., by not withdrawing delivery catheter 3304proximally) to confirm that he is satisfied with the shunt deploymentlocation in the patient before completely releasing shunt 200 fromdelivery catheter 3304. In embodiments of shunt 200 that do not includea proximal anchoring mechanism 227, step S060 is completed insubstantially the same manner, with shunt 200 releasing from the shuntdelivery shuttle 4316 and proximal portion of shunt deployed in the JV.

In the next step S065 of the procedure, the clinician removes deliverycatheter 3304 from the patient by withdrawing it proximally through thevenous vasculature and out of the patient at the femoral vein accesspoint. Optionally, the clinician holds guide member 780 in place whilewithdrawing delivery catheter 3304 proximally to ensure that anchor 700does not migrate proximally through IPS 102R and interfere with deployedshunt 200.

The clinician recaptures anchor 700 into the micro catheter and removesthe anchor from the patient via the femoral vein access point in stepS070 of the procedure. By feeding the proximal portion of guide member780 through the micro catheter lumen, the clinician can track the microcatheter distally over the guide member, around proximal anchoringmechanism 227 (if present) of the shunt deployed in the jugular vein 106or JV-IPS junction 118, until the distal end of the micro catheterreaches the joint 744 between the guide member and anchor. He can thenfurther advance the micro catheter distally and/or hold stationary orpull guide member 780 proximally to transition the anchor from itsdeployed or expanded configuration in the sinus lumen to its compressedconfiguration within the micro catheter lumen as shown in FIG. 55N. Withthe anchor compressed in the micro catheter lumen, the clinicianwithdraws the micro catheter and anchor from the patient proximally,through the venous vasculature and out of the femoral vein access point.Thereafter, he withdraws the guide catheter from the patient.

The deployed shunt 200 (shown in FIG. 55O) and valve 2209 provide aone-way flow conduit to drain excess CSF from the patient's subarachnoidspace into the jugular vein, thereby relieving the patient's elevatedintracranial pressure. The arrows in FIG. 55O depict the direction ofCSF flow from the CP angle cistern 138 into the shunt lumen 207, throughvalve 2209, and into jugular vein 106.

If in steps 5040 or 5045 of the procedure the clinician is unsuccessfulat penetrating IPS wall 114 at the target penetration site along thefirst curved portion 102A, he can continue the procedure by attemptingto penetrate IPS wall 114 along the second curved portion 102B of rightIPS 102R (e.g., as shown in FIG. 2C). For example, in certain patientanatomies, an overhang of the petrous bone can prevent penetratingelement 3350 from passing through IPS wall 114 into CP angle cistern138. The presence of this bony overhang can be confirmed during theshunt implant procedure by using one or more of the previously disclosedimaging modalities. The clinician can then continue the procedure byre-sheathing penetrating element 3350 with penetrating element guard4000, and advancing delivery catheter 3304 distally over guide member780 until the distal portion of delivery catheter 3304 is positioned ata target penetration site along the second curved portion 102B of rightIPS 102R. Optionally, the clinician can rotate delivery catheter 3304from about 45 to 180 degrees while tracking distally from the firstcurved portion 102A toward the second curved portion 102B in IPS 102R;by rotating the delivery catheter, the clinician can orient penetratingelement 3350 such that further distal advancement of delivery catheter3304 will advance penetrating element 3350 through IPS wall 114 at atarget penetration along the second curved portion 102B of right IPS102R. The clinician can continue the procedure and deploy shunt 200through IPS wall 114 along the second curved portion 102B of right IPS102R as previously described in steps 5030-5070 of the procedure.

Embodiments of shunt 200 that have been deployed in IPS 102 can beretrieved using a minimally invasive retrieval procedure guided by oneor more of the imaging methods previously disclosed. The clinician canadvance a guide catheter through the patient's vasculature (e.g., from afemoral vein access point in the patient) to the JV-IPS junction 118.The guide catheter can be advanced until the proximal end of thecatheter is proximate to the proximal end of shunt 200 deployed in theJV or further advanced until the proximal portion of the shunt 200 iscontained within the distal portion of the guide catheter lumen. Theclinician can then navigate a micro catheter (e.g., any of the 0.027″micro catheter embodiments previously disclosed) through the guidecatheter until the distal opening 3317 of the micro catheter isproximate to the proximal end of the deployed shunt. An anchor 700 withelongate guide member 780 is then translated through the micro catheter,for example, using the elongated pusher 3710 and corresponding method ofuse as previously disclosed. The clinician can deploy anchor 700 fromthe distal opening 3317 of micro catheter 3307 and adjust the locationof the expanded anchor 700 within the JV (and/or guide catheter lumen)until the proximal portion of the shunt is contained within the lumen ofanchor 700 and/or the proximal portion of the shunt 200 has passedthrough one of the cells of anchor 700. The clinician then re-sheathsthe anchor 700 into the micro catheter 3307, thereby compressing theproximal portion of shunt 200 within anchor 700 inside the microcatheter. The clinician can then withdraw the micro catheter proximallyuntil the distal anchoring mechanism 229 of the shunt in CP anglecistern 138 collapses and passes through IPS wall 114. The clinician canfurther withdraw the micro catheter into the guide catheter lumen andcontinue withdrawing the micro catheter from the patient to complete theshunt retrieval procedure. The retrieval procedure can also be completedusing commercially available thrombectomy devices or embodiments ofencapsulating shroud XXXX in addition to the anchor 700 as describedabove. After shunt retrieval, for example, to prevent bleeding into theCP angle cistern 138 through the penetration tract in IPS wall 114, theclinician can temporarily deploy a balloon in the IPS to stop bleeding,deploy a covered stent in the IPS at the penetration site, or embolizethat portion of the IPS using commercially available embolizationdevices (e.g., coils, particles, foam, adhesives).

FIGS. 56A-E illustrate an alternate embodiment of shunt 2200. Shunt 2200includes a distal anchoring mechanism 2229 (i.e., malelcot), as well asa retaining element 2230 comprising a radiopaque material, which elementwill be further described below. Distal anchoring mechanism 2229includes arms or tines 2229 a comprising a hinge, living joint, or thelike 2229 b, as previously described herein. The shunt 2200 furthercomprises a shunt body 2203, CSF lumen 2207, and a one-way valve 2209located in the proximal portion 2204 of the shunt.

The shunt body 2203 can have an elongate cylindrical configuration asdepicted in FIG. 56A and extend between the distal 2202 and proximal2204 portions of the shunt. Shunt body comprises CSF lumen 2207, e.g.,as illustrated in the cross-section views of FIGS. 56C-D. Shunt body2203 can include an elastomeric polymer(s) suitable for implantapplications including, but not limited to, silicone, polyurethane,polycarbonate urethane, thermoplastic polyurethane, aromatic oraliphatic polycarbonate thermoplastic polyurethane,silicone/polyurethane blends (e.g., thermoplastic silicone polycarbonatepolyurethane comprising 20% silicone copolymer), or polyurethanesilicone blends (e.g., polyurethane silicone copolymer). The durometerof the elastomer shunt body 2203 can range from about 15A to about 80A;for a silicone-based shunt body, the durometer can range from about 15Ato about 80A, and for a urethane-based shunt body, the durometer canrange from about 55A to about 80A. A shunt body 2203 comprised of anelastomeric polymer(s) advantageously resists thrombus formation on theportions of the implanted shunt in the blood flow of the IPS and jugularvein. Optionally, shunt 2200 can include an anti-thrombotic coating toprevent thrombus formation including, but not limited to, heparin-basedor phosphorylcholine-based anti-thrombotic coatings. To further preventthrombus formation, the length of shunt body 2203 can be configured suchthat the proximal portion 2204 and valve 2209 are located proximal tothe IPS-JV junction 118 (e.g., by 0.25″ or more) when implanted in thepatient's vasculature; junction 118, a location where the IPS and JVblood flows intersect, can experience more turbulent blood flow and havea higher risk for thrombus formation on an implant and valve portionplaced in the junction as compared to a location where the proximalportion of the shunt and valve are placed more proximally in the jugularvein, away from junction 118.

FIG. 56C illustrates a cross section of shunt 2200. The cross section ofshunt body 2203 includes a shunt body wall thickness “W” in FIG. 56C.The wall thickness of an elastomer shunt body 2203 can range from about0.001 inch to about 0.010 inch. The diameter of the CSF lumen 2207 ofshunt 2200 can range from about 0.010 inch to about 0.020 inch. Theouter diameter of shunt body 2203 can range from about 0.006 inch toabout 0.040 inch. The length of shunt body 2203 can range from about0.25″ to 3.0″ (6.35 mm 76.2 mm) to or more.

FIGS. 56B-D illustrate distal portion 2202 of shunt 2200. With referenceto FIG. 56B, retaining element 2230 comprises a radiopaque material(e.g., gold or other radiopaque material disclosed herein) and thedistal portion 2207 a of CSF lumen 2207 (further described herein).Anchoring mechanism 2229 can include a radiopaque marker located in thedistal collar 2229 c. When shunt 2200 is deployed from a shunt deliverycatheter, anchoring mechanism 2229 transitions (e.g., self-expands) froma compressed configuration within the delivery catheter (e.g., denotedby the dotted line portion “C” marked on FIG. 56B) to its open ordeployed configuration shown in FIG. 56B, during deployment, theclinician can observe the marker of distal collar 2229 c move toward theradiopaque retaining element 2230 to confirm that the distal anchoringmechanism 2229 has properly transitioned to its deployed state in CPangle cistern 138.

FIGS. 56C-D illustrate cross sections of the distal portion 2202 ofshunt 2200 and the connection between distal anchoring mechanism 2229and shunt body 2203 using one embodiment of a retaining element 2230.Retaining element 2230 includes a lumen that forms the distal or CSFinflow portion 2207 a of CSF lumen 2207 of the shunt and embodiments canhave the same range of internal diameters as described above for CSFlumen 2207 of shunt body 2203. Retaining element 2230 further includes atapered portion 2233 to accommodate a curved portion of distal anchoringmechanism arms 2229 a when the distal anchoring mechanism 2229 is in acompressed or delivery configuration; tapered portion 2233 also preventsretaining element 2230 from slipping proximally through the proximalportion 2229 e of distal anchoring mechanism 2229 (e.g., duringassembly).

The distal portion 2203 a of shunt body 2203 is secured within thedistal anchoring mechanism 2229. As shown in FIGS. 56C-D, distal portion2203 a of shunt body 2203 is compressed between the outer surface ofretaining element 2203 and inner surface of the proximal portion 2229 eof distal anchoring mechanism 2229. For example, distal portion 2229 eof distal anchoring mechanism 2229 can be compressed (e.g., crimped,swaged) over the distal portion 2203 a of the shunt body and retainingelement 2230. Further, retaining element 2230 can include retainingfeatures 2266 (e.g., circumferential threads as shown in FIGS. 60C-D,barbs, tines, hooks, or the like) to secure the distal portion 2203 a ofshunt body 2203 over retaining element 2230 and within the proximalportion 2229 e of distal anchoring mechanism 2229.

FIG. 56E shows proximal portion 2204 of shunt 2200. Proximal portion2204 includes a one-way valve 2209. Valve 2209 comprises a slit valveconfiguration with a single slit 2241 aligned with the longitudinal axisof shunt body 2203. This alignment can advantageously resist thrombusformation when implanted as it is also aligned generally with thedirection of blood flow through the jugular vein and minimizes bloodturbulence across the surface of proximal portion 2204 of the shunt.Proximal portion 2204 further includes a radiopaque marker 2227 c, themarker may be disposed between a proximal plug 2207 c and the valve2209, or the plug 2207 c may include radiopaque materials. Theradiopaque marker 2227 c is configured to assist shunt visualization ina patient during follow up clinical visits. The proximal plug 2207 c isconfigured to close the proximal opening of the lumen 2207 of the shunt2200.

Embodiments of valve 2209 can include one slit 2241 (e.g., as shown inFIGS. 29 and 56E) or multiple slits 2241 located around thecircumference of shunt body 2203 to achieve a desired opening orcracking pressure for the valve and/or target CSF flow rate at a nominaldifferential between ICP and venous blood pressure (e.g., any of theopening or cracking pressures described herein, any of the CSF flowrates described herein). The slit 2241 can be orthogonal to the surfaceof shunt body 2203 (e.g., as shown in FIGS. 29 and 56E) or angledrelative to such surface. Each slit 2241 can range from about 1 to 3 mm,or longer. Slit 2241 can be located in the proximal portion 2204 ofshunt 2200 (e.g., as shown in FIG. 56E) or located more distally orproximally (e.g., extending to the proximal end of shunt 2200 and/orinto plug 2207 c described below). With a cylindrically configured shuntbody 2203, the hoop strength of shunt body 2203 about slit 2241 preventsbacklow of fluid (e.g., blood) through valve into CSF lumen 2207; forexample, the valve remains closed and does not allow blood to leak intoCSF lumen 2207 when venous blood pressures on the exterior of the shuntelevate above CSF pressure in the shunt lumen 2207 and intracranialcompartment (e.g., CP angle cistern 138). Indeed, embodiments of valve2209 have demonstrated backflow prevention with simulated venous bloodpressures exceeding intracranial pressures by more than 175 mm Hg.

The proximal portion of CSF lumen 2007 can include a plug 2207 c toclose CSF lumen 2207 at its proximal end. Plug 2207 c can comprise thesame elastomeric material of shunt body 2203 or any of the otherpolymeric materials disclosed herein. Shunt 2200 can also include aradiopaque marker in the proximal portion of the shunt body 2203. Plug2207 c can be doped with a radiopaque material (e.g., barium sulfate,tantalum, or the like) or plug 2207 c and/or proximal portion 2204 ofthe shunt can include a marker band comprising any of the radiopaquematerials disclosed herein (e.g., a marker can be embedded in plug 2207c, shunt body 2203, or fixed thereto). The plug 2207 c can have anatraumatic configuration (e.g., rounded end), as shown in FIG. 56E, or amore elongate tapering configuration, or be squared off with respect tothe longitudinal axis of shunt body 2203.

FIGS. 57A-D illustrate the connection between distal anchoring mechanism2229 and shunt body 2203 with an alternate embodiment of retainingelement 2230. For ease in illustration and disclosure, the features,functions, and configurations of the shunt that are the same as in theshunt of the present disclosure (e.g., FIGS. 56A-E) are incorporated byreference herewith; the differences will be described in further detailbelow. Retaining element of FIG. 57A comprises a cylindrical elementthat forms the distal or CSF inflow portion 2207 a of CSF lumen 2207 ofshunt 2200, as illustrated in the cross-section views of FIGS. 57C-D.Retaining element 2230 can comprise titanium, stainless steel, Nitinol,or other super-elastic alloys. Retaining element 2230 can be connectedto the proximal portion 2229 e of distal anchoring mechanism 2229 (e.g.,weld or adhesive placed through one or more openings 2229 d in thedistal anchoring mechanism 2229). A cylindrical marker band 2240 can beswaged over the distal portion 2203 a of shunt body 2203 and retainingelement 2230 to secure the connection between the shunt body and distalanchoring mechanism. The distal collar 2229 c of anchoring mechanism2229 can include a radiopaque marker (not shown in FIG. 57A-D). Whenshunt 2200 is deployed from a shunt delivery catheter, anchoringmechanism 2229 transitions (e.g., self-expands) from a compressedconfiguration within the delivery catheter (e.g., denoted by the dottedline portion “C” marked on FIG. 57C) to its open or deployedconfiguration shown in FIG. 57B; during deployment, the clinician canobserve the marker of distal collar 2229 c move toward the radiopaquemarker band 2240 to confirm that the distal anchoring mechanism 2229 hasproperly transitioned to its deployed state.

Shunts comprising an elastomeric body 2203 (e.g., shunt 2200 of FIGS.56A-58F) can advantageously compress and elongate to facilitatetranslation through a delivery catheter lumen in a deployment procedure.For example, shunt body 2203 can compress radially up to about 80%(e.g., such that compressed shunt diameter is about 20% of its restingdiameter). Further, shunt body 2203 can extend, stretch, or elongatelongitudinally up to about 400% of its resting length. The compressionand elongation features of shunt body 2203 can be leveraged to maintaina relatively smaller profile (e.g., outer diameter) of a deliverycatheter and facilitate delivery catheter access and navigation andshunt implantation through narrow and/or tortuous vasculature.

FIGS. 58A-F illustrate an embodiment of shunt 2200 that includes theconnection between distal anchoring mechanism 2229 and shunt body 2203with an retaining element 2230 illustrated in FIG. 57A-D. FIGS. 58A-Ffurther include the valve 2209, marker 227 c and proximal plug 2207 c ofFIG. 57A-D. As shown in FIGS. 58C-F, the distal collar 2229 c of distalanchoring mechanism 2229 includes a radiopaque marker band 2240 toconfirm that the distal anchoring mechanism 2229 has properlytransitioned from a compressed configuration in the delivery catheterlumen to a deployed configuration in CP angle cistern 138.

FIGS. 59-63B illustrates an embodiment of a shunt delivery shuttle 7000for translating and deploying a shunt 2200 (e.g., embodiments of shunt2200 illustrated in FIGS. 56A-58F) through the second lumen 3305 of adelivery catheter 3304 (e.g., any of the delivery catheter embodimentsdisclosed herein including the delivery catheter illustrated in FIG.64A-E). The shunt delivery shuttle 7000 includes a distal shuttleportion 7016 (e.g., mesh, braid, shroud, stent-like, funnel-like,tubular body, or other configurations), coupled to an elongate proximalpusher 7012 (e.g., wire or elongated pushing member) via a junction7014. The distal shuttle portion 7016 of the shunt delivery shuttle 7000comprises a proximal portion 7016 a and a distal portion 7016 b, havinga lumen 7018 extending therebetween. The distal shuttle portion 7016 ofthe shunt delivery shuttle 7000 is configured to receive, retain, pushand/or shuttle the shunt 2200. As illustrated in FIGS. 59A, 61A, 62A-Cand 63C, the proximal portion 7016 a of the distal shuttle portion 7016tapers toward junction 7014.

The distal shuttle portion 7016 of the shunt delivery shuttle 7000 cancomprise a self-expanding braid, and is shown in an expandedconfiguration in FIG. 59. The distal shuttle portion 7016 is configuredto receive shunt 2200 (e.g., within the lumen 7018) and is configured tocompress and elongate (e.g., FIG. 63A-B) suitable for translation withinthe second lumen 3305 of the delivery catheter for translating the shunt2000 through the catheter, into the implantation site of a patient. Witha lined lumen (e.g., PTFE-lined second lumen of delivery catheter 3304),the distal shuttle portion 7016 of the shunt delivery shuttle 7000facilitates smooth transition of an elastomeric shunt 2200 through thedelivery catheter. The expanded or resting diameter of distal shuttleportion 7016 of the shunt delivery shuttle 7000 can range from about 0.5mm to about 6 mm. The compressed length of the shunt delivery shuttle7000 (e.g., when compressed in a delivery catheter lumen) can range fromabout 0.25″ to 3.0″ (6.35 mm 76.2 mm) or more.

The distal shuttle portion 7016 of the shunt delivery shuttle 7000includes multiple filaments 7020 that are weaved to form the braidstructure, as illustrated by the inset of FIG. 59A. Filaments cancomprise Nitinol (e.g., heat-set), stainless steel, or a polymer (e.g.,PTFE, HDPE, PET, PEEK, Kevlar). Embodiments of the distal shuttleportion 7016 of the shunt delivery shuttle 7000 can include 8 to 144filaments. Filaments 7020 of the distal shuttle portion 7016 can haveround or non-round cross-sections; round cross-section filaments canhave a diameter from about 0.0002 inch to about 0.005 inch. Filaments7020 can be cut in the distal portion 7016 b of the distal shuttleportion 7016 (e.g., as illustrated in FIG. 59), rounded, or braided backproximally toward the distal shuttle portion 7016 midsection to create amore atraumatic profile for the distal portion 7016 b of the distalshuttle portion 7016.

The elongate proximal pusher 7012 can have a round or non-roundcross-sectional profile. Embodiments of elongate proximal pusher 7012with a round cross section can have a diameter of about 0.0006 to about0.030 inch. The elongate proximal pusher 7012 can be solid or include alumen to accommodate other delivery assembly components. Nitinol,stainless steel, or other like materials can be used for elongateproximal pusher 7012, provided the overall design provides sufficientcolumn strength to deliver a shunt 2200 in the shunt delivery shuttle7000 through a delivery catheter lumen and into a target implant site.The distal portion of the elongate proximal pusher 7012 can include atapered grind or other features (e.g., cuts, slots, kerfs or the like)to increase the flexibility of such distal portion, which can facilitateshunt translation through the delivery catheter when the catheter isbeing used in tortuous anatomy. Junction 7014 can be formed by gatheringthe proximal ends of the filaments 4320 of the distal shuttle portion7016 of the shunt delivery shuttle 7000 over the distal portion of theelongate proximal pusher 7012 and using a heat shrink material over thefilaments and wire, by using a direct connection (e.g., by adhesive orwelding, e.g., gathering the filaments over the wire and under aradiopaque marker band), or using any of the shunt-tether interlockconfigurations disclosed herein.

Alternate embodiments of shunt delivery shuttle 7000 can include any ofthe anchor 700 configurations disclosed herein as a substitute for thedistal shuttle portion 7016 of the shunt delivery shuttle 7000 fortranslating shunt 2200 through delivery catheter 3304. For example, asshown in FIGS. 60A-63C, the shunt delivery shuttle 7000 can be formedfrom a hypo tube with a wall thickness from about 0.0005 inch to about0.004 inch. The strut width of the shunt delivery shuttle 7000 can rangefrom about 0.0002 inch to about 0.003 inch; the strut width can varyalong the length of the shunt delivery shuttle 7000 (e.g., creating astiffer proximal portion of the shunt delivery shuttle 7000 tofacilitate translation of the shunt through the delivery catheter lumenand a more flexible distal portion of the shunt delivery shuttle 7000radially capture shunt 2200). FIGS. 62A-62E illustrate alternativejunction 7014 between the distal shuttle portion 7016 of the shuntdelivery shuttle 7000 and the elongate proximal pusher 7012, thejunction 7014 uses any suitable coupling mechanism or technique.

FIGS. 63A-C illustrate the shunt and the shunt delivery shuttleaccording to the embodiments of the invention. FIG. 63A shows the shunt2200 and the shunt delivery shuttle 7000 separately, while FIGS. 63B and63C show the interface between the shunt 2200 and the shunt deliveryshuttle 7000. The shunt delivery shuttle 7000 is configured to be atleast partially positioned within the lumen of, and movable relative to,the delivery catheter. The distal shuttle portion 7016 of the shuntdelivery shuttle 7000 is configured to collapse around the elongateshunt body 2203 (FIG. 63B) to thereby transport the shunt body 2203through the delivery catheter lumen, wherein the distal shuttle portion7016 self-expands (FIG. 63C) to release the shunt body 2203 when thedistal shuttle portion 7000 is advanced out of the delivery catheterlumen through the opening of the tissue penetrating element.

FIGS. 64A-E illustrate another embodiment of the delivery catheter 3304embodiments described in connection with FIGS. 19A-I, 20, 21A-M, 30A-F.For ease in illustration and disclosure, the features, functions, andconfigurations of the delivery catheter that are the same as in thedelivery catheter of the present disclosure (e.g., FIGS. 19A-I, 20,21A-M, 30A-F) are incorporated by reference herewith; the differenceswill be described in further detail below. The delivery catheterillustrated in FIGS. 64A-E has received an elongate guide member 780through first lumen 3315 of the penetrating element guard or guardmember 4000 and delivery catheter 3304. Penetrating element guard 4000is disposed over penetrating element 3350 to guard against inadvertentpunctures in the vasculature while tracking the delivery catheter to thetarget penetration site in IPS wall 114. As described in connection withFIGS. 20, 21, and 31, the penetrating element guard 4000 can translateproximally over the distal portion of the delivery catheter to exposethe penetrating element 3350 at the target penetration site in the IPS.

Penetrating element guard 4000 illustrated in FIGS. 64A-E includes adeflecting element 4030 to deflect penetrating element 3350 away fromthe elongate guide member 780 and towards a target penetration site inthe patient's vasculature. FIG. 64B illustrates a cross-section of adistal portion of the delivery catheter including penetrating elementguard 4000 and deflecting element 4030. FIG. 64C illustrates furtherdetails of the deflecting element 4030 illustrated in FIGS. 64A-B.Deflecting element 4030 includes proximal 4032 and distal 4034 portions.Distal portion 4034 can facilitate delivery catheter access into narrowor tortuous vasculature.

During a shunt deployment procedure, penetrating element guard 4000 isretracted proximally over the delivery catheter to expose penetratingelement 3350 at the target penetration site; as the guard 4000 retractsproximally, the proximal portion 4032 of deflecting element 4032contacts the bevel of penetrating element 3350. As the clinician furtherretracts penetrating element guard 4000 proximally, deflecting element4030 (e.g., proximal portion 4032) deflects penetrating element awayfrom elongate guide member 780. To achieve this deflection forpenetrating element 3350, the angle of the proximal portion 4032 ofdeflecting element 4030 relative to the longitudinal axis of elongateguide member 780, as illustrated by angle “Φ” in FIG. 64C, can rangefrom about five degrees to about 30 degrees, or more. Deflecting element4030, by increasing the angle of the penetrating element relative to theplane of the elongate guide member 780, increases the distance orseparation between the penetrating element tip and guide member 780(e.g., illustrated as D1 in FIG. 64C). Deflecting element 4030facilitates tissue puncture in challenging patient anatomies, e.g., in aportion of the IPS 102 or CS 104 that runs relatively parallel to CPangle cistern 138. For example, if the patient has a significant petrousbone overhang that prevents penetration through IPS wall 114 at thefirst turn 102A of IPS 102 (see FIGS. 2A-B), the clinician can use adelivery catheter and shuttle embodiment as illustrated in FIGS. 64A-Eto penetrate IPS wall 114 beyond the petrous bone overhang, for example,between the first 102A and second 102B turns of IPS 102.

Deflecting element 4030 can be added to penetrating element guard 4000using an ultraviolet light-cured adhesive or epoxy material.Alternatively, penetrating element guard 4000 and deflecting element4030 can be molded as a single part. Materials for molded embodiments ofthe penetrating element guard and deflecting element can include Nylon,Pebax, polyurethane, or any other polymeric material disclosed hereinfor use with guard 4000 or delivery catheter 3304.

FIGS. 64D-E illustrate cross-section views of the delivery catheter 3304shown in FIGS. 64A-C at reference line “DIE” of FIG. 64B (e.g., throughmarker band 4015 embedded in guard 4000). As shown in FIGS. 64D-E,delivery catheter 3304 includes a second shuttle pull wire 4012. Pullwire 4012 includes a distal portion 4013 and connection point 4013 a,which are illustrated in FIGS. 64D-E. Delivery catheter 3304 includes afourth lumen 3335 (not shown) configured to receive the second pull wire4012. A dual pull wire configuration of delivery catheter 3304 canprovide smoother penetrating element guard 4000 retraction proximallyover penetrating element and provide smoother distal retraction of guard4000 to re-cover penetrating element 3350 compared to single pull wireembodiments.

FIGS. 65A-C illustrate embodiments of radiopaque markers that enable anclinician to discern delivery catheter 3304 and penetrating element 3350orientation in the patient's vasculature under flouroscopy. FIG. 65Aillustrates marker bands 3370, 3372, and 3374 applied to reinforcingmember 1345 of a delivery catheter 3304. FIG. 65B illustrates thepatterns used to apply the marker bands shown in FIG. 65A; pattern 3370a of FIG. 65B corresponds to marker 3370 of FIG. 65A, patterns 3376 athrough 3376 j of FIG. 65B corresponds to markers 3372 a through 3372 jof FIG. 65A, and pattern 3378 of FIG. 65B corresponds to marker 3374 ofFIG. 65A. FIG. 65A illustrates catheter assembly alignment features 3374a-c of marker band 3374.

The markers illustrated in FIG. 65A can comprise gold plating (or otherradiopaque materials) applied in the patterns reflected in FIG. 65B toreinforcing member 1345. The plating can range in thickness from about0.0002 inch to about 0.002 inch. Distal marker band 3370 includesorienting features illustrated in FIGS. 65A-B and can be aligned axiallywith the bevel of penetrating element 3350 to help the clinician discernpenetrating element orientation in vivo (e.g., under flouroscopy whendeliver catheter 3304 has advanced into IPS 102). Additional dimensionsof marker band 3370 and pattern 3370 a used to form marker band 3370 areincluded in FIGS. 65A-B. Markers 3372 a through 3372 j comprise a seriesof marker bands placed with equal spacing between each band (e.g., 1 cmspacing between marker bands as illustrated in FIG. 65A) to provide theclinician with a reference point and measurement tool when deliverycatheter has navigated to IPS 102. Each marker band 3372 a through 3372j is approximately 1 mm wide, although other widths are possible. WhileFIG. 65A illustrates ten marker bands at equal 1 cm spacing between eachband as the bands extend proximally from marker band 3372 a, otherconfigurations and spacing are possible. Orienting feature 3374 b ofmarker band 3374 can also be aligned axially with the bevel ofpenetrating element 3350 to help the clinician discern penetratingelement orientation in vivo. Orienting feature 3374 c provides areference point during manufacturing to ensure proper assembly andfunction of delivery catheter 3304. For example, elongate guide member780 and first lumen 3315 of the delivery catheter can be axially alignedto orienting feature 3374 c. In addition, one or more shuttle pull wires(e.g., pull wire 4010, pull wire 4012) and the corresponding pull wirelumens (e.g., third lumen 3325, fourth lumen 3335) can be axiallyaligned to orienting feature 3374 c. Additional dimensions and featuresof marker 3374 are included in FIGS. 65A-B.

FIG. 66 illustrates an embodiment of a handle assembly 6000 for use witha delivery catheter 3304. Handle assembly 6000 includes three maincomponents: a needle hub 6002, a double hemostasis valve “Y” connector6004, and a vented male Luer cap 6018; vendor and part number detailsare provided for these components on FIG. 66. The proximal end ofdelivery catheter 3304 extends through needle hub 6002 into the distalhub of Y connector 6004 as illustrated in FIG. 66. The elongate proximalpusher 7012 of shunt delivery shuttle 7000 extends proximally from thedelivery catheter 3304 through a first hemostasis valve 6010 in Yconnector 6004 as illustrated in FIG. 66. Shuttle pull wires 4010 and4012 extend proximally from their respective lumens in delivery catheter3304 through a second hemostasis valve 6020 in Y connector 6004. Theproximal ends of shuttle pull wires 4010, 4012 extend through a femaleLuer lock and are fixed (e.g., welded, bonded with adhesive) to theunderside of male Luer cap 6018. Hypotubes are used to provideadditional support to shuttle pull wires 4010, 4012 in the secondhemostasis valve portion 6020 of Y connector 6004: a smaller hypotube6012, 6014 is placed over each of shuttle pull wires 4010 and 4012. Thepull wire and smaller hypotubes are passed through a larger hypotube6016 shown in FIG. 66. Hypotubes can have any suitable dimensionscompatible with handle 6000 (e.g., standard hypotube gauging,dimensions, and materials can be ascertained fromhttps://www.vitaneedle.com/hypodermic-tube-gauge-chart/). Dimensions andother details of hypotubes 6012, 6014, and 6014 are as follows: largerhypotube 6016 is 15 regular wall×1.89″; smaller hypotubes 6012, 6014 are26 thin wall×2.05 inches. The hypotubes 6012, 6014, and 6014 subassemblyin the second hemostasis valve 4020 portion of Y connector 6004 providesadditional support and column strength for shuttle pull wires 4010, 4012to enable smooth and consistent proximal and distal actuation ofpenetrating element guard 4000 via cap 6018.

When handle assembly 6000 is in use with a delivery catheter 3304,unscrewing cap 6018 from Luer lock 6022 initiates proximal retraction ofpenetrating element guard 4000; after unscrewing cap 6018 from Luer lock6022, the clinician can pull proximally on cap 6018 to further retractguard 4000 over penetrating element 3350. The clinician can then usedelivery catheter 3304 to penetrate IPS wall. Handle assembly 6000includes an aspiration/flush port 6006 that includes a lumen fluidicallycontiguous with second lumen 3305 of delivery catheter 3304; byattaching a syringe (e.g., 1 ml syringe) to the proximal end of port6006, the operator can aspirate CSF from CP angle cistern 138, throughpenetrating element lumen 3355, delivery catheter lumen 3305, and port6006 to observe CSF collecting in the syringe and confirm penetrationthrough IPS wall into the subarachnoid space; alternative embodiments ofhandle assembly 6000 do not include aspiration/flush port 6006. Theshunt delivery shuttle 7000 can be used to advance shunt 2200 fromdelivery catheter lumen 3305 and penetrating element lumen 3355 untildistal anchoring mechanism 2229 deploys in CP angle cistern 138. Port6006 can also be used to flush saline or contrast through lumen 3305 andout of penetrating element lumen 3355 into the patient's vasculature atdifferent points during the shunt implant procedure. By reversing theforegoing sequence described for cap 6018 (e.g., pushing distally on cap6018 and screwing cap 6018 onto Luer lock 6022, the operator can advanceguard 4000 distally clinician and re-cover penetrating element 3350(e.g., after shunt implantation and while withdrawing delivery catheterfrom the patient).

It should be appreciated that if the clinician inadvertently causes atear in IPS wall 114, the clinician may elect to abort the procedure. Ifusing an embodiment of anchor 700 that includes an outer polymeric layerthat covers the cells of the anchor and a guide member 780 that candetach from anchor 700, he can, redeploy anchor 700 in the sinus lumenacross the tear and leave the anchor 700 in the IPS 102 by detachingguide member 780; in this scenario, the anchor can prevent venous bloodfrom leaving into the subarachnoid space and/or uncontrolled CSF leakingfrom the subarachnoid space into the venous system.

FIGS. 67-A-H illustrates alternative delivery catheter, pusher member3310 and shunt 2200 interfaces, and respective interlocking members3336, constructed according to embodiments of the disclosed inventions.As shown in FIG. 67A, the interlocking member 3336 of the pusher 3310engages the outer surface of the shunt 2200, which radially compresseswithout longitudinally stretching the shunt 2200 and thereby reducesfriction of the shunt 2200 with the delivery catheter inner wall.

In FIGS. 67B-C, the interlocking member of the pusher 3310 engages theouter surface of the delivery catheter. In these embodiments, frictionof the shunt 2200 with the delivery catheter may be reduced and thevalve (not shown) of the shunt would be not engaged with the pushermember 3310, since the interlock member is mounted on the outer surfaceof the catheter. In alternative embodiments, the interlocking member3336 of the pusher depicted in FIGS. 67B-C can be constrained within thelumen of a delivery catheter, as previously described in connection withother pusher embodiments disclosed herein.

As shown in FIG. 67D-E, the shunt 2200 may be further compressed (e.g.,folded, bent, or the like) within the lumen of the delivery catheter3304 for more efficient packing during delivery of the shunt at thetarget site.

Alternatively or additionally, the shunt 2200 may be compressed duringdelivery by the shunt delivery shuttle 7000 having a stent-likestructure, as shown in FIGS. 67F-G. In these embodiments, the shuntcomprises a polymeric body and anchoring mechanism (e.g., silicon) as itwill be described in further detail below.

In yet another alternative embodiment, the interlocking members 3336 ofthe pusher and the interlocking members 3337 of the shunt include matingelements, such as a protrusion and a slot, as shown in FIGS. 67H-I. Theengagement of the interlocking members may be further assisted by areduced inner diameter of the delivery catheter (not shown), magneticelements, or the like.

Although particular embodiments have been shown and described herein, itwill be understood by those skilled in the art that they are notintended to limit the present inventions, and it will be obvious tothose skilled in the art that various changes, permutations, andmodifications may be made (e.g., the dimensions of various parts,combinations of parts) without departing from the scope of the disclosedinventions, which is to be defined only by the following claims andtheir equivalents. The specification and drawings are, accordingly, tobe regarded in an illustrative rather than restrictive sense. Thevarious embodiments shown and described herein are intended to coveralternatives, modifications, and equivalents of the disclosedinventions, which may be included within the scope of the appendedclaims.

1. An endovascular shunt implantation system, comprising: a guide memberhaving a distal portion configured for being deployed in an inferiorpetrosal sinus (IPS) of a patient; a delivery catheter movably coupledto the guide member, wherein a distal end of the delivery cathetercomprises or is otherwise coupled to a tissue penetrating element, suchthat the delivery catheter and tissue penetrating element aretranslatable relative to the distal portion of the guide member withinthe IPS; a guard member at least partially disposed over, and movablerelative to, the tissue penetrating element, the guard member having anopen distal end portion including an inner surface feature configured todeflect the tissue penetrating element away from the guide member whenthe tissue penetrating element is translated distally relative to theguard or when the guard is withdrawn proximally relative to the tissuepenetrating element; and a shunt delivery shuttle at least partiallypositioned within a lumen of, and movable relative to, the deliverycatheter, the shunt delivery shuttle comprising an elongate proximalpusher coupled to a distal shuttle portion configured to collapse aroundan elongate shunt body to thereby transport the shunt body through thedelivery catheter lumen, wherein the distal shuttle portion self-expandsto release the shunt body when the distal shuttle portion is advancedout of the delivery catheter lumen.
 2. The endovascular shuntimplantation system of claim 1, further comprising an expandable anchorconfigured for being deployed in a dural venous sinus of the patient ata location distal to a target penetration site located on a curvedportion of the IPS wall, wherein the elongate guide member is coupledto, and extends proximally from, the anchor.
 3. The endovascular shuntimplantation system of claim 2, further comprising a guide member pushertool configured for translating the respective guide member and anchorrelative to the IPS, wherein the pusher tool comprises a handle having alumen extending therethrough, and a tubular body portion coupled to thehandle, the tubular body portion comprising a lumen that is contiguouswith or otherwise extends through the handle lumen, the respectivehandle and tubular body lumens being configured to receive the guidemember, wherein the handle is configured to allow selective engagementand release of a portion of the guide member extending proximallythrough the handle lumen for thereby pushing the guide member, and thusthe anchor, distally.
 4. The endovascular shunt implantation system ofclaim 2, wherein the dural venous sinus comprises the IPS.
 5. (canceled)6. The endovascular shunt implantation system of claim 3, wherein thehandle comprises a proximal facing surface configured to mate with ahuman thumb or finger in order to selectively engage or release theguide member using said thumb of finger.
 7. The endovascular shuntimplantation system of claim 1, wherein the guard member comprises atubular guard body having a first guard body lumen or recess configuredto receive the penetrating element, and a plurality of pull wires, eachpull wire having a distal portion fixed within or otherwise attached tothe guard body, wherein the pull wires are configured to translate theguard body proximally or distally relative to the delivery catheter soas to at least partially expose or cover, respectively, the penetratingelement.
 8. The endovascular shunt implantation system of claim 1,wherein the open distal end portion of the guard member has a beveled ortapered portion, and wherein the inner surface feature is located onsaid beveled or tapered portion.
 9. The endovascular shunt implantationsystem of claim 1, wherein the guard member comprises a lumen configuredto accommodate passage therethrough of the guide member.
 10. Theendovascular shunt implantation system of claim 1, further comprising anendovascular shunt device, the shunt device comprising an elongate shuntbody held within the collapsed distal shuttle portion of the shuntshuttle within the delivery catheter lumen, and a distal shunt anchorcoupled to a distal end of the shunt body and extending distally fromthe distal shuttle portion of the shunt shuttle, wherein the distalshunt anchor self-expands when advanced out of the delivery catheterlumen through the opening of the tissue penetrating element.
 11. Theendovascular shunt implantation system of claim 10, wherein the shuntdevice further comprises one or more cerebrospinal fluid (CSF) intakeopenings in a distal portion of the shunt that are in fluidcommunication with a shunt lumen extending through the shunt body, theshunt body comprising one or more longitudinal slits configured to allowegress therethrough of CSF in the shunt lumen if a fluid pressure withinthe shunt lumen exceeds a body fluid pressure external of the one ormore slits, and wherein a proximal end of the shunt body is fluidlysealed.
 12. The endovascular shunt implantation system of claim 11,wherein the shunt device further comprises a tubular connector having aproximal portion secured to a distal end of the shunt body, a distalportion secured to the distal shunt anchor, and an open distal endlocated within the distal shunt anchor, the open distal end of thetubular connector comprising the one or more CSF intake openings. 13.The endovascular shunt implantation system of claim 12, wherein thetubular connector is radiopaque or otherwise has one or more radiopaqueelements coupled thereto.
 14. The endovascular shunt implantation systemof claim 10, wherein the shunt body comprises a flexible unreinforcedpolyurethane-silicone blend or other polymer.
 15. The endovascular shuntimplantation system of claim 1, wherein the inner surface feature of theguard member comprises at least a partial bead of material applied to ormolded as part of an inner surface of the guard member, and wherein thedistal shuttle portion comprises a wire mesh or cut tube.
 16. (canceled)17. An endovascular shunt implantation system, comprising: a guidemember having a distal portion configured for being deployed in aninferior petrosal sinus (IPS) of a patient; a delivery catheter movablycoupled to the guide member, wherein a distal end of the deliverycatheter comprises or is otherwise coupled to a tissue penetratingelement, such that the delivery catheter and tissue penetrating elementare translatable relative to the distal portion of the guide memberwithin the IPS of the patient, the delivery catheter comprising a lumenin communication with an opening in the tissue penetrating element; anda guard member at least partially disposed over, and movable relativeto, the tissue penetrating element, the guard member having an opendistal end portion including an inner surface feature configured todeflect the tissue penetrating element away from the guide member whenthe tissue penetrating element is translated distally relative to theguard or when the guard is withdrawn proximally relative to the tissuepenetrating element.
 18. The endovascular shunt implantation system ofclaim 17, wherein the guard member comprises a tubular guard body havinga first guard body lumen or recess configured to receive the penetratingelement, and one or more of pull wires, each having a distal portionfixed within or otherwise attached to the guard body, wherein the one ormore pull wires are configured to translate the guard body proximally ordistally relative to the delivery catheter so as to at least partiallyexpose or cover, respectively, the penetrating element.
 19. Theendovascular shunt implantation system of claim 17, wherein the opendistal end portion of the guard member has a beveled or tapered portion,and wherein the inner surface feature is located on said beveled ortapered portion.
 20. The endovascular shunt implantation system of claim17, wherein the guard member comprises a lumen configured to accommodatepassage therethrough of the guide member, and wherein the inner surfacefeature of the guard member comprises at least a partial bead ofmaterial applied to or molded as part of an inner surface of the guardmember.
 21. (canceled)
 22. An endovascular shunt implantation system,comprising: a guide member having a distal portion configured for beingdeployed in an inferior petrosal sinus (IPS) of a patient; a deliverycatheter movably coupled to the guide member, wherein a distal end ofthe delivery catheter comprises or is otherwise coupled to a tissuepenetrating element, such that the delivery catheter and tissuepenetrating element are translatable relative to the distal portion ofthe guide member within the IPS of the patient, the delivery cathetercomprising a lumen in communication with an opening in the tissuepenetrating element; and a shunt delivery shuttle at least partiallypositioned within the lumen of, and movable relative to, the deliverycatheter, the shunt delivery shuttle comprising an elongate proximalpusher coupled to a distal shuttle portion configured to collapse aroundan elongate shunt body to thereby transport the shunt body through thedelivery catheter lumen, wherein the distal shuttle portion self-expandsto release the shunt body when the distal shuttle portion is advancedout of the delivery catheter lumen through the opening of the tissuepenetrating element.
 23. (canceled)
 24. The endovascular shuntimplantation system of claim 22, wherein the elongate proximal pusher ofthe shunt delivery shuttle comprises a lumen. 25-45. (canceled)